MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71938-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.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 while charging.No further details are available at this time.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 was performed on the returned reader and no damage was observed.Usb charger and usb cable were not returned with the reader.No evidence of reader being "too hot to hold" was observed.Built-in reader test was performed and the test was passed.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 signs of damage, burn marks or corrosion was observed.Returned battery voltage was measured and result was within the specification.Reader was monitored under thermal camera during operation and temperature was observed to be above 30°c.An extended investigation was performed.A visual inspection was performed on the returned device.No damage was observed to the printed circuit board assembly (pcba) or the reader casing.The initial scan was reviewed and no issues were observed.The device was brought to a lab bench for testing.The returned battery voltage was measured.Which was within the required threshold.The reader did power on with a button press, strip test, and charging cable.A thermal camera was used to review the reader¿s temperature when the reader was powered on as well as while charging and no hot spots were observed.A reader self-test was performed and the reader was passed with no issues observed.The customer reported complaint of the reader being hot to hold was not observed.No evidence of a product malfunction was observed during the investigation.Since no evidence of a product malfunction was found during the investigation, this 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 dhr for the libre reader and kit pack for verification of correct cable and adapter was reviewed.The dhrs showed the libre reader passed all tests prior to release and correct cable and adapter was part of the kit pack.If partial product is returned, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.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 while charging.No further details are available at this time.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 14 DAY
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 21439499
• Report Number: 2954323-2025-06665
• Device Sequence Number: 17294342
• Product Code: PZE
• UDI-Device Identifier: 00357599002008
• UDI-Public: (01)00357599002008(10)01B347D
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160030
• 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): 11/12/2025

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: 71938-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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