Model Number 1000096 |
Device Problems
Filling Problem (1233); Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
Event Type
malfunction
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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 submitted upon completion of the evaluation.
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Event Description
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It was reported that a minimum fill notification occurred after the user filled the cartridge with 280 units of insulin during the load sequence.Customer¿s blood glucose level was 328 mg/dl.Reportedly, the customer reverted to manual injections for insulin therapy.
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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 (damaged usb pins).
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Search Alerts/Recalls
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