| Model Number 71992-01 |
| Device Problem
Device Alarm System (1012)
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| Patient Problems
Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418); Sweating (2444)
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| Event Date 11/16/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Abbott diabetes care product quality engineering (pqe) investigated the alarm-2 (signal loss alarm) complaint.The serial number of the freestyle libre 2 sensor associated with this complaint is unknown.During investigation of the track and trend review related to alarm-2 cases in (b)(6) 2020, this failure mode was identified and is a known manufacturing issue that impacts libre 2 sensors manufactured at flex buffalo grove (fbg).As the serial number of the sensor associated with this complaint is unknown, pqe is unable to determine if the sensor is impacted by this manufacturing issue.Outside of the known manufacturing issue, the available tripped trend reports for libre 2 sensor and alarm-2 have been reviewed.The review did not identify any additional trends that would indicate a product related issue related to this complaint.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date is unknown.The date entered 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 signal loss alarm issue was reported with the adc freestyle libre 2 sensor.A customer reported that the loss of signal resulted in the blood glucose alarm failing to trigger.The customer experienced symptoms described as "dizzy, short breath, wet, sweaty," and subsequently lost consciousness.The customer awoke on their own and self-treated with grape sugar.The customer had contact with a healthcare provider who recommended they contact adc.No additional treatment was reported.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor patch and no physical damage was observed.The sensor plug was observed properly seated.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).The low temperature threshold value was checked and observed to be set at 00.Further investigation identified that the low temperature ratio parameter was configured incorrectly.This incorrect value prevented the bluetooth integrated circuit from being turned on at normal operating temperatures, resulting in no bluetooth communication between the puck and the reader.Therefore, this issue is confirmed.An extended investigation has also been performed for the reported complaint.Adc product quality engineering (pqe) investigated this alarm-2 (signal loss alarm) complaint.It was determined that the freestyle libre 2 sensor reported in this complaint was manufactured at flex buffalo grove (fbg) with the incorrect low temperature ratio parameter of zero (0).The low temperature ratio parameter setting should be set at 187.The incorrect low temperature ratio parameter will prevent the sensor bluetooth low-energy (ble) radio from enabling in the operational temperature range, and as a result the system will not be able to present glucose alarms.This failure mode was identified during investigation of the track and trend review related to alarm-2 cases in april 2020.This issue was addressed in the field by adc fa1027-2020.Dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.The temperature ratio setting is in the machine software and therefore, not captured in the dhr.Qr728102 was initiated to investigate and address this issue on 16-may-2020.Immediate as well as corrective and preventative actions include: ¿ software on affected kit pack lines has been updated to prevent the resetting of the low temperature parameter to ¿0¿.This action was completed on 28-may-20.O impacted product within manufacturing control was determined to either be immediately scrapped or reworked.Rework and scrap of all impacted product was completed 26-jan-21.O update packaging line test limits and associated packaging line validation protocols to include applicable product software parameters for verification.This will ensure that the validation of additional packaging lines will include all the appropriate parameters for successful verification and validation.The completion date of this corrective action was 11-dec-20.O update validation process to include requirements to perform functional testing of product to user requirement specifications.This corrective action was implemented on 09-feb-21.All pertinent information available to abbott diabetes care has been submitted.Section g4 (serial number) has been updated based on the returned product.Section g1: (contact office first name, contact office last name, contact office phone number and contact office email) has been updated.Section h4: (device mfg date) has been updated based on the returned product investigation.Section d4: (expiration date) has been updated based on the returned product investigation.
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Event Description
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A signal loss alarm issue was reported with the adc freestyle libre 2 sensor.A customer reported that the loss of signal resulted in the blood glucose alarm failing to trigger.The customer experienced symptoms described as "dizzy, short breath, wet, sweaty," and subsequently lost consciousness.The customer awoke on their own and self-treated with grape sugar.The customer had contact with a healthcare provider who recommended they contact adc.No additional treatment was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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