Model Number 71953-01 |
Device Problems
Failure to Power Up (1476); Unable to Obtain Readings (1516); Battery Problem (2885)
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Patient Problems
Hypoglycemia (1912); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
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Event Date 04/26/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 record) 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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A customer reported being unable to test with the adc device due to the reader "unable to charge reader." as a result, customer reported experiencing hallucinations, confusion, tremors, body jerkins and was unable to self-treat.The customer required third-party intervention of glucagon injection for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported being unable to test with the adc device due to the reader "unable to charge reader." as a result, customer reported experiencing hallucinations, confusion, tremors, body jerkins and was unable to self-treat.The customer required third-party intervention of glucagon injection for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The returned reader was investigated.The reader was visually inspected and observed damaged to the internal pins of the usb port.The pins were damaged due to incorrect cable into the reader or excessive force applied for inserting the cable into the readers usb port.Thus, the usb port is unable to function.The reader was de-cased and placed into the text fixture to download the log.Although glucose results may be delayed, blood glucose could be determined by alternate means, including use of another blood glucose meter, seeing a physician (as recommended in product labeling), or by seeking treatment at a health care facility.Issue is not confirmed to use due to damaged usb port.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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