TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number 1002717 |
Device Problem
False Alarm (1013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.
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Event Description
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It was reported that an altitude alarm occurred.Reportedly, the pump was outside the labeled altitude operating range; however, alarm was unable to be cleared.Customer's blood glucose level was not impacted by the event.Reportedly, the customer reverted to an alternate form of insulin therapy.
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