Model Number 71953-01 |
Device Problems
No Device Output (1435); 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 07/08/2022 |
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.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 complaint was received regarding the adc device turning on by button by not by test strips.As a result, on (b)(6) 2022, the customer experienced ¿terrible dreams¿ and had a seizure and a loss of consciousness.The customer was provided cassis and honey by a non-healthcare professional and healthcare professional 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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Reader (b)(6) has been reader and investigated.Visually inspected the reader and no issues were observed.Reader turned on with button and strip insertion.Visually inspected the usb/charging cable and no issues were observed.Date and time was set using returned cable and known good reader.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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A complaint was received regarding the adc device turning on by button by not by test strips.As a result, on (b)(6) 2022, the customer experienced ¿terrible dreams¿ and had a seizure and a loss of consciousness.The customer was provided cassis and honey by a non-healthcare professional and healthcare professional for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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