Device Problem
Failure to Prime (1492)
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Patient Problems
Hypoglycemia (1912); Sweating (2444)
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Event Type
Injury
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Manufacturer Narrative
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The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
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Event Description
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On (b)(6) 2016, the patient contacted animas, alleging a prime (loss of prime) issue.The patient stated that they had a blood glucose (bg) 36mg/dl with sweating.The patient stated that they self-treated with a glucagon injection.Customer support (cs) completed troubleshooting and cs advised the patient to not continue to fill cannula while attached as this stop is not required for the pump to lose its prime.This report is being made due to the bg excursion the patient experienced due to a prime issue.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 11/10/2016 with the following findings: the black box shows loss of prime warning associated with low non-zero force leading to delivery interruptions.An ezprime and a 24hr duration test were successfully completed with no loss of prime warnings being duplicated.The pump is detecting the correct force.The tdd¿s add up correctly and reflect the users programmed basal rates.Pump passed delivery accuracy testing with no delivery defects found.Pump found to be delivering within required range and delivering accurately.Removed pump cover; force sensor pins seated and solder connections intact.No evidence of contamination or cracked force sensor traces.No evidence of internal moisture was found.Unidentified force low observed in the black box, force sensor calibration in specifications.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.(b)(4).
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Search Alerts/Recalls
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