Model Number 71953-01 |
Device Problem
Output Problem (3005)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 03/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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The customer reported that the adc device would not provide readings from test strips.The customer experienced a loss of consciousness and reported they received treatment of biscuits and juice by both a third-party and healthcare provider.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided for the strips.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that precision strips continue to be safe, effective, and perform as intended in the field.Stability data for precision strips was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and precision strips, no trends were identified that would indicate any product related issues.The dhrs (device history review) for the libre reader were reviewed and the dhrs 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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The customer reported that the adc device would not provide readings from test strips.The customer experienced a loss of consciousness and reported they received treatment of biscuits and juice by both a third-party and healthcare provider.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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