Model Number 71953-01 |
Device Problems
No Device Output (1435); Unable to Obtain Readings (1516)
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Patient Problems
Fatigue (1849); Hyperglycemia (1905); Vomiting (2144)
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Event Date 10/04/2023 |
Event Type
Injury
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Event Description
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A testing issue was reported with the adc device.The customer reported the test did not start after the blood sample was applied and he was unable to obtain readings.As a result, customer experienced symptoms of fatigue, vomiting, dehydration, and was unable to self-treat.Customer had contact with a healthcare professional at the hospital who provided 14 units of insulin infusion as treatment for the diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
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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.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 device.The customer reported the test did not start after the blood sample was applied and he was unable to obtain readings.As a result, customer experienced symptoms of fatigue, vomiting, dehydration, and was unable to self-treat.Customer had contact with a healthcare professional at the hospital who provided 14 units of insulin infusion as treatment for the diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Additional information: section d4 (serial no) & (udi) were updated based on the returned product.Reader (b)(6) was returned and investigated with retained strip.Performed a visual inspection on the returned reader and no issue was observed.The returned reader powered on with button depression and with insertion of retained strips.A control solution test was performed, and the returned reader did not start after the sample was applied.The meter was sent for further investigation and de-cased.Upon visual inspection of the de-cased readers¿ printed circuit board assembly (pcba), and poor solder joint on the reader strip port pins which prevented the customer from performing glucose strip test.Applied pressure and re-flowed solder on the strip port pins, observed control solution test passed.Therefore, this issue is confirmed to poor solder on strip port pins.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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