Model Number 71953-01 |
Device Problem
Computer Software Problem (1112)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 10/19/2023 |
Event Type
Injury
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Event Description
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Customer reported her adc blood glucose meter was reading in the incorrect uom and incorrect language.Customer further reported experiencing a loss of consciousness.Customer reported she was unable to self-treated requiring third-party treatment from a healthcare professional of "dextro" and something to eat.There was no report of death or permanent impairment associated with this event.
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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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle libre reader were reviewed and the dhrs showed the freestyle 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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Manufacturer Narrative
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Reader (b)(6)has been returned and investigated.Visual inspection has been performed on the reader and no issues were observed.The unit of measurement were set successfully.The returned reader was connected to pc and investigation was performed for reported complaint.The reported issue was unable to be reproduced and the reader functioned as intended.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer reported her adc blood glucose meter was reading in the incorrect uom and incorrect language.Customer further reported experiencing a loss of consciousness.Customer reported she was unable to self-treated requiring third-party treatment from a healthcare professional of "dextro" and something to eat.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 has been performed on the reader and no issues were observed.The unit of measurement of the reader has been tested and no specification was observed.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer reported her adc blood glucose meter was reading in the incorrect uom and incorrect language.Customer further reported experiencing a loss of consciousness.Customer reported she was unable to self-treated requiring third-party treatment from a healthcare professional of "dextro" and something to eat.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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