TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
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Model Number 1000096 |
Device Problem
Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that the pump indicated a data log corruption.Customer's blood glucose level ranged from 120-129 mg/dl.Reportedly, the pump was replaced to resolve issue and customer continued to use the pump for 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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