MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD LIBRE 3 SENSOR FREESTYLE; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Muscle Weakness (1967)

Event Date 10/28/2022

Event Type  Injury  

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.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.

Event Description

A caller reported a sensor error with the adc device, which caused loss of signal no sensor readings.As the customer was unable to obtain sensor readings, they went to school nurse when they became weak.A capillary result of 64 mg/dl was obtained, and the customer treated with juice and food.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.The sensor was attempted to be scan with evm(evaluation module), sensor did not scan.The evm (evaluation module) was reset and the sensor was scan again, sensor did not scan.Data was not successfully extracted.Communication was attempted between returned sensor and known good reader.The sensor was further de-cased and visual inspection was performed on the pcba(printed circuit board assembly) and no issues were observed.The returned sensor battery was measured and the result was within specification.The battery was unsoldered from pcba (printed circuit board assembly).The sensor was attempted to be scan with evm (evaluation module).The sensor scan was successful.An extended investigation has been performed.Visual inspection was performed on the returned sensor, no issues were observed.The battery was soldered from the pcba and the evm successfully read the sensor.The root cause of the complaint was unable to be determined if it was poor solder on the battery contacts due to no visual evidence provided of the original condition of the solder joints prior to desoldering the battery during phase1.Thus adc is unable to further test the returned product.Therefore, the issue is closed to no product returned.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported a sensor error with the adc device, which caused loss of signal no sensor readings.As the customer was unable to obtain sensor readings, they went to school nurse when they became weak.A capillary result of 64 mg/dl was obtained, and the customer treated with juice and food.There was no report of death or permanent injury associated with this event.

Event Description

A caller reported a sensor error with the adc device, which caused loss of signal no sensor readings.As the customer was unable to obtain sensor readings, they went to school nurse when they became weak.A capillary result of 64 mg/dl was obtained, and the customer treated with juice and food.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.The sensor was attempted to be scan with evm(evaluation module), sensor did not scan.The evm (evaluation module) was reset and the sensor was scan again, sensor did not scan.Data was not successfully extracted.Communication was attempted between returned sensor and known good reader.The sensor was further de-cased and visual inspection was performed on the pcba(printed circuit board assembly) and no issues were observed.The returned sensor battery was measured and the result was within specification.The battery was unsoldered from pcba (printed circuit board assembly).The sensor was attempted to be scan with evm (evaluation module).The sensor scan was successful.An extended investigation has been performed.Visual inspection was performed on the returned sensor, no issues were observed.The battery was soldered from the pcba and the evm successfully read the sensor.The root cause of the complaint was unable to be determined if it was poor solder on the battery contacts due to no visual evidence provided of the original condition of the solder joints prior to desoldering the battery during phase1.Section h6 (investigation findings) code c20 (no findings available) 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.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the previous report.Correction has been made.

• Brand Name: LIBRE 3 SENSOR FREESTYLE
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 15794730
• MDR Text Key: 303628853
• Report Number: 2954323-2022-41687
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599818006
• UDI-Public: 30357599818006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: VERIFY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male