Model Number 1000096 |
Device Problems
Incorrect Measurement (1383); Pumping Stopped (1503)
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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 which resulted in the pump shutting down.There was no reported adverse impact to the customer¿s blood glucose level.The 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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Manufacturer Narrative
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The failure investigation has been completed.Based on the analysis, the alleged issue could not be verified; however, a different issue was identified.
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Search Alerts/Recalls
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