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

Model Number 71953-01

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and damage to the usb port was observed.Visual inspection was performed on the returned usb/charging cable and no issues were observed.The usb/charging cable passed all test's.Visual inspection was performed on the returned power adapter and no issues were observed.The power adapter's voltage was measured at 4.90v, which was within specification of 4.75v-5.25v.The observed damage to the usb port would prevent the customer from charging the reader which would lead to the reader not turning on.Therefore, the issue is not confirmed.The dhrs (device history review) for the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports their adc device is too hot to hold while charging.No further details are available at this time.There was no report of fire, smoke, explosion, or shock.There was no report of death, serious injury, or mistreatment associated with this event.Issues involving thermal events occurring with adc freestyle libre and libre 2 readers is associated with report of corrections and removal number 2954323-02/09/23-001-c, submitted to the fda on 09-feb-23.Adc field action fa1005-2023 was issued to the us 09feb23.

• 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: 19060597
• MDR Text Key: 339667100
• Report Number: 2954323-2024-11836
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: (01)00357599803001(10)02B007F
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QUALITY RECORD QR869779
• Patient Sequence Number: 1
• Patient Sex: Female