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

Model Number	71938-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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 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.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.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 and a valid serial number has not been provided for the strip.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that precision strips continue to be safe, effective, and perform as intended in the field.Stability data for precision strips was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and precision strips, no trends were identified that would indicate any product related issues.Dhrs (device history review) for the libre reader were reviewed and the dhrs (device history review) showed the libre reader passed all tests prior to release.If 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.
Additional Manufacturer Narrative
The returned reader was investigated with retained test strips.Visual inspection was performed on returned reader.No new issues were observed.Control solution testing has been performed with two returned strips and all results were within range specification.Therefore, 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.A dhr (device history review) for the fs libre reader was reviewed and the dhr showed the fs libre reader passed all tests prior to release.Dhr for the precision strips was reviewed and the dhr showed the precision strips passed all tests before release.Retain testing was performed for the precision strips and all units performed within specification.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Event or Problem Description
Customer reported receiving a high reading from their abbott diabetes care device.Customer reported a high reading of 335mg/dl which was higher than a freestyle libre scan reading of 165mg/dl.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Reader (b)(6) has been returned and investigated with retained test strips.Visual inspection has been performed on the reader and no issues were observed.Blood testing was unable to perform as returned strips had been used previously with control solution.Control solution testing was performed and no issues were observed.All results were within range specification.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE READER 14 DAY
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 20063142
• Report Number: 2954323-2024-32301
• Device Sequence Number: 18052240
• Product Code: PZE
• UDI-Device Identifier: 00357599002008
• UDI-Public: (01)00357599002008(10)03Z002D
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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 Expiration Date: 10/31/2024
• Device Model Number: 71938-01
• Device Lot Number: 4500187332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 01/16/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/01/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown