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 11/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that an altitude alarm occurred while the customer was not outside of the labeled operating altitude range.There was no reported impact to the customer's blood glucose level.Reportedly, the customer reverted to an alternate method of insulin therapy.
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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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Search Alerts/Recalls
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