Model Number 1002717 |
Device Problem
Filling Problem (1233)
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Patient Problems
Hyperglycemia (1905); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2022 |
Event Type
malfunction
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Event Description
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It was reported that insulin drips were not observed to be exiting the infusion set tubing during the load fill tubing process.There was no reported adverse impact to the customer¿s blood glucose level.Reportedly, no further troubleshooting was performed and a replacement pump was sent to the customer for customer satisfaction.Customer reverted back to manual injections for insulin therapy.
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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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Manufacturer Narrative
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H6 - remove codes - 2199, 4582.Add: 1905, 4613.
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Event Description
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It was reported that insulin drips were not observed to be exiting the infusion set tubing during the load fill tubing process.Customer blood glucose (bg) level was reported as "high" (specific value was not provided) with trace ketones; cause was unknown.Customer gave a bolus via pump and manual injection to address bg level.Reportedly, the customer changed supplies multiple times to resolve the issue; however, the customer reverted back to manual injections for insulin therapy.
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Search Alerts/Recalls
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