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  "name": "t:connect mobile app used in conjunction with  t:slim X2 insulin pump with Control-IQ technology",
  "description": "FDA recall Z-1609-2024 — Tandem Diabetes Care, Inc. is recalling t:connect mobile app used in conjunction with  t:slim X2 insulin pump with Control-IQ technology (Devices, Class I). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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    "name": "t:connect mobile app used in conjunction with  t:slim X2 insulin pump with Control-IQ technology",
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      "name": "FDA recall Z-1609-2024: Tandem Diabetes Care, Inc. is recalling t:connect mobile app used in conjunction with  t:slim X2 insulin pump with Control-IQ technology",
      "text": "The FDA logged enforcement record Z-1609-2024: Tandem Diabetes Care, Inc. is voluntarily recalling t:connect mobile app used in conjunction with  t:slim X2 insulin pump with Control-IQ technology — reason: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-05. Affected lots/codes: version 2.7 or later /UDI: 00850006613274. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-1609-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Value": "During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US nationwide distribution including Puerto Rico.",
            "Status": "recorded"
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