Model Number 72114-01 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Blurred Vision (2137); Shaking/Tremors (2515); Convulsion/Seizure (4406)
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Event Date 03/17/2024 |
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 mfg 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 high readings issue was reported with the abbott diabetes care (adc) device.The customer received unspecified high sensor scan results compared to readings obtained on a competitor's brand meter.The customer experienced symptoms described as "severe shaking, fingers and arms tingled, the soles of feet burned, blurred vision, hands were cramped, could not grab anything", and a seizure.The customer was unable to self-treat and had contact with a healthcare professional who provided cola for the diagnosis of hypoglycemia.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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Sensor 0fw6e2840 has been returned and investigated.Visual inspection has been performed and no issues were observed on sensor patch.Data was downloaded successfully, sensor state 7 with event log 11 and 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.De-cased the returned sensor and performed visual inspection of the printed circuit board assembly (pcba), damage to the antenna was observed.Attempted to communicate the sensor with evaluation module (evm) before source measure unit (smu) testing but was unable to do so due to inventory command fail message observed.Extended investigation and visual inspection has been performed on the returned de-cased sensor, observed that the antenna and molex connector had been damaged during de-casing and is unable to be re-soldered/repaired due to the solder pads coming away from the pcba.This damage will render the antenna unable to communicate.Unable to perform functionality testing without the antenna connected and will be unable to continue investigation as sensor is no longer in its original condition or a condition to perform functionality testing.Therefore, this issue is unable to test.Section h6 (investigation findings) code c20 (no findings available) and d15 cause not established was selected, as adc was unable to perform further testing on the returned device.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A high readings issue was reported with the abbott diabetes care (adc) device.The customer received unspecified high sensor scan results compared to readings obtained on a competitor's brand meter.The customer experienced symptoms described as "severe shaking, fingers and arms tingled, the soles of feet burned, blurred vision, hands were cramped, could not grab anything", and a seizure.The customer was unable to self-treat and had contact with a healthcare professional who provided cola for the diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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