Model Number 1000354 |
Device Problems
Pumping Stopped (1503); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that a malfunction alarm occurred.Additionally, it was reported that the wake button was unresponsive.Pump display turned on when plugged into a power source.The customer reverted to an alternate method of insulin therapy.Customer¿s blood glucose level was 80 mg/dl.
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Manufacturer Narrative
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The failure investigation has been completed and the malfunction issue was verified.Based on the analysis, the wake button issue could not be verified.
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Search Alerts/Recalls
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