Model Number 1000354 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2022 |
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 the wake button was unresponsive.Pump display turned on when plugged into a power source.Customer¿s blood glucose was 123 mg/dl.Reportedly 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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Event Description
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It was reported that the wake button was unresponsive.Pump display turned on when plugged into a power source.Customer¿s blood glucose was xx mg/dl.Customer continued to use the pump for insulin therapy.Or it was reported that the wake button was unresponsive.Pump display turned on when plugged into a power source.Customer¿s blood glucose was xx mg/dl.Customer reverted to an alternate method of insulin therapy.
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Search Alerts/Recalls
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