Model Number 71953-01 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problems
Hypoglycemia (1912); Dizziness (2194)
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Event Date 05/07/2023 |
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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A battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device not holding charge.As a result, the customer experienced dizziness and was unable to self-treat.The customer had contact with a health-care professional (hcp) who administered intravenous glucose for treatment.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.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, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device not holding charge.As a result, the customer experienced dizziness and was unable to self-treat.The customer had contact with a health-care professional (hcp) who administered intravenous glucose for treatment.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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