Model Number 71953-01 |
Device Problems
Failure to Power Up (1476); Unable to Obtain Readings (1516)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 10/29/2023 |
Event Type
Injury
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Event Description
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An incorrect product delivery issue associated with a replacement adc device was reported.The customer initially reported that a battery/no power issue occurred with the adc device and was issued a replacement device.Due to delivery issue, customer was unable to test and experienced loss of consciousness, seizure, double tongue talking, spasms in jaw and legs.The ambulance was called to the customer home and upon arrival, the customer received glucose intravenously for diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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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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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 reader & cable adapter.Therefore, it is not possible to check dhr for cable and adapter.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.A tripped trend review was conducted for the reported complaint and fs libre reader no trends were identified that would indicate any product related issues.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.Upon extended investigation, it was determined that the serial number provided by the customer (b)(6) and previously reported to the fda was not a valid serial number.
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Event Description
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An incorrect product delivery issue associated with a replacement adc device was reported.The customer initially reported that a battery/no power issue occurred with the adc device and was issued a replacement device.Due to delivery issue, customer was unable to test and experienced loss of consciousness, seizure, double tongue talking, spasms in jaw and legs.The ambulance was called to the customer home and upon arrival, the customer received glucose intravenously for diagnosis of hypoglycemia.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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