MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problems Low Readings (2460); Material Twisted/Bent (2981)

Patient Problem Hypoglycemia (1912)

Event Date 06/01/2023

Event Type  Injury  

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a customer reported that their adc device gave low readings and frequently alarms for low glucose.The customer obtained a blood glucose reading of 54 mg/dl while the strip showed 210 mg/dl.It was indicated that the customer compared readings for the next 3 days and the difference in readings continued.The customer was contacted again and additionally reported a bent sensor tip issue.No further information was provided.There was no report of any self or third-party medical treatment reported.Based on the information provided, there was no report of serious injury associated with this event.

Manufacturer Narrative

This issue does not meet reportability criteria; however, it is being reported to the fda as the complaint was received via user report.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 kits were reviewed, and the dhrs showed the libre sensor and libre sensor kits 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

Abbott diabetes care received a medwatch report which reported the following information: a customer reported that their adc device gave low readings and frequently alarms for low glucose.The customer obtained a blood glucose reading of 54 mg/dl while the strip showed 210 mg/dl.It was indicated that the customer compared readings for the next 3 days and the difference in readings continued.The customer was contacted again and additionally reported a bent sensor tip issue.No further information was provided.There was no report of any self or third-party medical treatment reported.Based on the information provided, there was no report of serious 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.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 1(indicating the sensor was never activated by the customer).No malfunction or product deficiency was identified.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor and no issues were observed.The sensor plug was properly seated.Watermark was not observed at the base of the tail.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sensor pack (b)(6) has been returned and investigated.Visual inspection was performed on the returned sensor pack and no issues were observed.Sensor plug assembly and sharp was observed inside sensor pack.The lid was completely peeled off.The platform was inspected and no issues were observed.Applicator (b)(6) has been returned and investigated.Visual inspection was performed on the returned applicator and no issues were observed.The applicator has been fired correctly.Therefore, issue is not confirmed to tail not properly inserted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a customer reported that their adc device gave low readings and frequently alarms for low glucose.The customer obtained a blood glucose reading of 54 mg/dl while the strip showed 210 mg/dl.It was indicated that the customer compared readings for the next 3 days and the difference in readings continued.The customer was contacted again and additionally reported a bent sensor tip issue.No further information was provided.There was no report of any self or third-party medical treatment reported.Based on the information provided, there was no report of serious injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17321426
• MDR Text Key: 319010351
• Report Number: 2954323-2023-30270
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 71992-01
• Device Catalogue Number: 71992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 01/31/2024; 01/31/2024
• Supplement Dates FDA Received: 02/09/2024; 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1