MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION PRO; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	71411-70
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported product has been returned and is currently undergoing investigation.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported erroneous glucose results from a hospital abbott diabetes care device.The health care professional reported a blood glucose results of 501 mg/dl compared to a reading of 156 mg/dl respectively obtained from a blood glucose lab and the results, when plotted on a parkes error grid, fall 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
Meter (b)(6) has been returned and investigated with a known-good retained battery.Visual inspection performed on the returned meter and strip port module and no issue was observed.Installed retain batteries into the meter.Meter powered on with button depression.Lcd was observed during power up/ self-test sequence and no issues were observed.Control solution test was performed and the result was within the specification range.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.The precision strip has been requested back for an investigation and the customer agreed to return the device.However, precision strip has not been received at this time despite follow up attempts by adc.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 strip continue to be safe, effective, and perform as intended in the field.Stability data for precision strip 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 the precision strip; no trends were identified that would indicate any product related issues.Dhrs (device history review) for the precision pro meter was reviewed and the dhrs showed the precision pro meter met specifications prior to release to distribution.Dhrs (device history review) for the strip port module was reviewed and the dhrs showed the strip port module met specifications prior to release to distribution.If the 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
A health care professional reported erroneous glucose results from a hospital abbott diabetes care device.The health care professional reported a blood glucose results of 501 mg/dl compared to a reading of 156 mg/dl respectively obtained from a blood glucose lab and the results, when plotted on a parkes error grid, fall 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.

• Brand Name: FREESTYLE PRECISION PRO
• Common Device Name: BLOOD 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: 24600361
• Report Number: 2954323-2026-14558
• Device Sequence Number: 20921477
• Product Code: NBW
• UDI-Device Identifier: 00093815714125
• UDI-Public: (01)00093815714125(10)04E143D
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: Health Professional
• Device Model Number: 71411-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown