Model Number 72081-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Dizziness (2194); Polydipsia (2604)
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Event Date 07/17/2023 |
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 low readings issue with the adc device was reported.Customer received unspecified lower sensor scan results and experienced symptoms of thirst, nausea, and slight dizziness.A blood glucose result of 629 mg/dl was obtained from a laboratory test at the hospital, and the customer received intravenous fluids as treatment by a healthcare professional.No further information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A low readings issue with the adc device was reported.Customer received unspecified lower sensor scan results and experienced symptoms of thirst, nausea, and slight dizziness.A blood glucose result of 629 mg/dl was obtained from a laboratory test at the hospital, and the customer received intravenous fluids as treatment by a healthcare professional.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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Additional information: section h4 (device mfg date) was updated based on the returned product download.Sensor (b)(6) was returned and investigated.Visual inspection was performed on the returned sensor patch and no issue was observed.Data was extracted using approved software, and extraction was successful."sensor" was found to be in sensor state 8 with event log 9 are an indication that the sensor had terminated due to an error recognized by the sensor.This is a part of software design and is not an indication of product non-conformance.Watermark was observed at the base of the sensor tail indicating sensor tail was properly inserted.The returned reader was further investigated and de-cased.Visual inspection has been performed on the de-cased reader's pcba (printed circuit board assembly) and no issues were observed.Performed a source measure unit (smu) test which indicated no accuracy issues with the puck.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor¿s electronics were functioning as intended.The sensor passed functionality testing which indicates that the data quality errors observed did not have an impact on the sensor¿s functionality and electronics, therefore no malfunction or product deficiency was identified.This issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhr for the libre sensor and sensor kit indicated by the serial number provided by the customer was reviewed.The dhrs showed the libre sensor and sensor kits passed all tests prior to release and there was no indication that the product did not meet specifications.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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