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	07/03/2023
Type of Reportable Event	Malfunction
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
The most probable root causes associated with this failure mode are disconnected, faulty or damaged components or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint.Dhrs for the libre reader were reviewed and kit pack dhr was reviewed for verification of correct cable and adapter.The dhrs showed the libre reader passed all tests prior to release and the correct cable and adapter was a part of the kit pack.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
Reader (b)(6)has been returned and investigated.The customer did not return the usb charging cable and adapter.Visual inspection has been performed on the returned reader and no damage or evidence of customer¿s complaint was observed.No corrosion was observed.Built-in reader test was performed and all results were within specification.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 range.Reader was also monitored under thermal camera during operation, where no abnormal hot spots were observed.There was no evidence observed that would cause the reader to become ¿reader overheated" as reported by the customer.Therefore, the issue is not confirmed.If partial product is returned, the case will be re-opened, and a physical investigation will be performed.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: 18031039
• Report Number: 2954323-2023-47702
• Device Sequence Number: 17854701
• Product Code: QLG
• UDI-Device Identifier: 00357599805005
• UDI-Public: (01)00357599805005(21)MEGB100-G2036(10)03B251D
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K193371
• 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): 03/22/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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