Model Number 71953-01 |
Device Problem
No Device Output (1435)
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Patient Problems
Hypoglycemia (1912); Shaking/Tremors (2515)
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Event Date 09/11/2023 |
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 testing issue was reported with the adc reader.The test did not start after the blood sample was applied, and the customer was unable to obtain readings.As a result, the customer experienced hypoglycemia with symptoms described as "tremors, difficulty walking and was treated by the emergency services, where two oral glucose gels were administered 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 was not provided for the reader.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and libre reader, 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.Upon extended investigation, it was determined that the serial number provided by the customer (b)(6) and previously reported to the fda was not a valid serial number.
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Event Description
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A testing issue was reported with the adc reader.The test did not start after the blood sample was applied, and the customer was unable to obtain readings.As a result, the customer experienced hypoglycemia with symptoms described as "tremors, difficulty walking and was treated by the emergency services, where two oral glucose gels were administered 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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