Model Number 71953-01 |
Device Problem
No Device Output (1435)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912)
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Event Date 12/25/2022 |
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.A valid lot or serial number was not provided for the test strips.The dhrs (device history record) for the libre reader were reviewed, and the dhrs showed the libre reader passed all tests prior to release.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.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 that the adc device would not power on with test strip insertion.The customer therefore was unable to obtain glucose results and became fatigued, requiring treatment of sugar-water by third-party.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The reported reader ((b)(6).) was returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.Reader powered on with button depression and strip insertion, therefore this issue is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported that the adc device would not power on with test strip insertion.The customer therefore was unable to obtain glucose results and became fatigued, requiring treatment of sugar-water by third-party.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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