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

Model Number	71953-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's product has been returned for investigation.A follow-up report will be submitted once all investigation activities are complete.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reports their adc device is too hot to hold.No further details are available at this time.It is unknown if the customer's device was too hot to hold during use or while charging.There was no report of fire, smoke, explosion, or shock.It is unknown at this time if the charging cable and adapter used was the cable and adapter supplied by adc for use with the libre device.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.
Additional Manufacturer Narrative
Reader (b)(6)has been returned and investigated.Visual inspection has been performed on the returned reader and no damage or evidence of fire was observed.No corrosion was observed.The returned reader was further investigated and de-cased.Visual inspection has been performed on the de-cased reader's pcba (printed circuit board assembly) and no evidence of fire was observed.The returned battery voltage was measured, and a power consumption test was performed, and both were within specification.The current draw on the returned reader was within specification.Reader was also monitored under thermal camera during operation, where no abnormal hot spots were observed.The customer did not return the usb charging cable and adapter.There was no evidence observed that would cause the reader to become ¿too hot to hold" as reported by the customer.Therefore, the issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader and verification of correct cable and adapter were reviewed.The dhrs showed that the libre reader passed all tests prior to release and the correct cable and adapter were part of the kit pack.If partial product is returned, the case will be re-opened, and a physical investigation will be performed.Section h4 (device mfg date) has been modified.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reports their adc device is too hot to hold.No further details are available at this time.It is unknown if the customer's device was too hot to hold during use or while charging.There was no report of fire, smoke, explosion, or shock.It is unknown at this time if the charging cable and adapter used was the cable and adapter supplied by adc for use with the libre device.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
• Common Device Name: 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: 17918386
• Report Number: 2954323-2023-45501
• Device Sequence Number: 15149061
• Product Code: QLG
• UDI-Device Identifier: 00357599805005
• UDI-Public: 00357599805005
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K193771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: QUALITY RECORD QR869779
• Patient Sequence Number: 1
• Patient Sex: Unknown