TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
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Model Number 1002717 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/30/2022 |
Event Type
malfunction
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Event Description
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It was reported that the battery gauge was fluctuating.The customer's blood glucose was 300 mg/dl.Reportedly, customer reverted to manual injections for insulin therapy.
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Manufacturer Narrative
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The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.
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Search Alerts/Recalls
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