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

Model Number	72011-01
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.Installed retained batteries and the meter turns on with button depression.Observed lcd during power up/ self-test sequence, no issues observed.Performed control solution testing and it was satisfactory.Therefore, this issue is not confirmed.An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the product were reviewed and the dhrs showed the product passed all tests prior to release.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The customer obtained a glucose reading of 20 mg/dl on the adc device compared to a glucose reading of 300 mg/dl obtained on another adc meter.The results, when plotted on a parkes error grid, fall into the d 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.Visual inspection has been performed and no issues were observed.Installed retained batteries and the meter turns on with button depression.Observed lcd during power up/ self-test sequence, no issues observed.Performed control solution testing and it was satisfactory.Therefore, this issue is not confirmed.An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the product were reviewed and the dhrs showed the product passed all tests prior to release.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 led to the complaint.A tripped trend review was conducted for the reported complaint and the product; no trends were identified that would indicate any product related issues.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.This serves as a correction report.[sectionh11 - additional mfr narrative] was incorrectly updated in the previous report.Correction has been made.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 customer obtained a glucose reading of 20 mg/dl on the adc device compared to a glucose reading of 300 mg/dl obtained on another adc meter.The results, when plotted on a parkes error grid, fall into the d 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: 24372135
• Report Number: 2954323-2026-09560
• Device Sequence Number: 9744783
• Product Code: NBW
• UDI-Device Identifier: 00357599807009
• UDI-Public: (01)00357599807009(10)02C270D
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: Lay User/Patient
• Device Model Number: 72011-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown