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

Model Number 71952-01

Device Problems Unable to Obtain Readings (1516); Battery Problem (2885)

Patient Problem Hypoglycemia (1912)

Event Date 09/21/2021

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.Dhrs (device history record) for the libre reader were reviewed and the dhrs showed the libre reader 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 customer initially reported a battery/power issue with the freestyle libre 2 reader where "reader is not responding even though customer has tried plugging it into another cable, changing outlet, etc." and ordered a replacement device.The customer reported that due to a delay in delivery of the replacement device, he had no means to monitor glucose.Customer noted that he could not move or sleep and required treatment of glucose injection by third-party.There was no report of death or permanent injury associated with this event.

Event Description

A customer initially reported a battery/power issue with the freestyle libre 2 reader where "reader is not responding even though customer has tried plugging it into another cable, changing outlet, etc." and ordered a replacement device.The customer reported that due to a delay in delivery of the replacement device, he had no means to monitor glucose.Customer noted that he could not move or sleep and required treatment of glucose injection by third-party.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated with retained strip.Visual inspection has been performed on the returned reader and no issues were observed.The reader did not power on with button press or with strip insertion.The returned reader did power on with the usb cable.The reader was further investigated and de-cased.Performed a visual inspection on the returned reader printed circuit board assembly (pcba) and no issues with the component were observed and no contamination was observed.The returned battery measured as 0.00v.Placed returned reader into the reader printed circuit board assembly (pcba) test fixture and applied pressure to the central processing unit (cpu).The reader did power on when pressure was applied to the cpu and the battery was observed to be charging.Replaced returned battery with a new unused battery and attempted to turn on reader.Reader turned on with a new unused battery and battery was observed to be charging.Therefore, this issue is confirmed to faulty battery.All pertinent information available to abbott diabetes care has been submitted.

• 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: 12707531
• MDR Text Key: 278745360
• Report Number: 2954323-2021-90284
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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 Model Number: 71952-01
• Device Catalogue Number: 71953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White