Model Number 71953-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Tachycardia (2095); Dizziness (2194); Loss of consciousness (2418); Diaphoresis (2452); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
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Event Date 03/30/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.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 review) for the freestyle libre reader were reviewed and the dhrs showed the freestyle 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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An error message was reported with the adc device.Customer received an error 1 message on their adc reader display and was unable to obtain readings.As a result, customer experienced dizziness, trembling, disorientation, sweating, tachycardia, and loss of consciousness, requiring unspecified third-party treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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An error message was reported with the adc device.Customer received an error 1 message on their adc reader display and was unable to obtain readings.As a result, customer experienced dizziness, trembling, disorientation, sweating, tachycardia, and loss of consciousness, requiring unspecified third-party treatment.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Reader (b)(6) has been returned and investigated with retained test strips.Visual inspection has been performed on the returned reader and no issues were observed.The reader's date and time were successfully set and the reader's data log was downloaded.Control solution testing was performed and all results were within specifications and no errors were observed.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.No further investigation is required.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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