Model Number 71953-01 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problems
Hypoglycemia (1912); Vomiting (2144); Dizziness (2194); Loss of consciousness (2418); Diaphoresis (2452)
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Event Date 03/15/2024 |
Event Type
Injury
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Manufacturer Narrative
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The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhr) for the libre reader was reviewed and the dhr showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A message reported as error-9, or ¿errc-9,¿ was reported when testing with the abbott diabetes care (adc) device.As a result, the customer experienced symptoms including dizziness, sweating, diarrhea, vomiting and was unable to provide self-treatment due to symptoms and experienced a loss of consciousness.Customer was found by non-hcp, the wife, and was provided glucose tablets for treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Reader (b)(6) has been returned and investigated.Visual inspection was performed on the usb/charging cable and no damage was observed.Usb/charging cable was passing the test.Visual inspection was performed on the power adapter and no issues were observed.Performed load test on the returned power adapter and results were within specification range.Power adapter was passing the test.Visual inspection has been performed on the returned reader and no issues observed.Built-in reader test was performed and the reader passed the test.No error message was observed.Therefore, issue is not confirmed.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A message reported as error-9, or ¿errc-9,¿ was reported when testing with the abbott diabetes care (adc) device.As a result, the customer experienced symptoms including dizziness, sweating, diarrhea, vomiting and was unable to provide self-treatment due to symptoms and experienced a loss of consciousness.Customer was found by non-hcp, the wife, and was provided glucose tablets for treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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