MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FS PREC PRO-CODING; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	71284-70
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	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for investigation.A follow-up report will be submitted once additional information is obtained.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.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specifications.The dhrs for the freestyle precision pro meter was reviewed.The dhrs showed the freestyle precision pro meter passed all tests prior to release.The dhrs (device history review) for the precision strips was reviewed.The dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips and all units performed in specification and passed.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.
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
The returned meter was investigated with a known-good retained battery.Visual inspection was performed on returned meter and no issues were observed.Inserted retain batteries into the meter.Meter powered on with button depression.Lcd was observed to be powered up/ self-test sequence and no issues observed.Control solution testing was performed and all results are within specification.No issues were observed with returned meter.Therefore this issue is not confirmed.The strip has been requested back for an investigation and the customer agreed to return the device.However, strip has been received at this time despite follow up attempts by adc.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 healthcare professional reported a low reading from an abbott diabetes care blood glucose hospital meter.The healthcare professional reported a low blood glucose reading of 35 mg/dl compared to an abbott diabetes care blood glucose meter reading of 202 mg/dl.When plotted on a parkes error grid, the results fall in 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: FS PREC PRO-CODING
• Common Device Name: BLOOD 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: 13052394
• Report Number: 2954323-2021-96249
• Device Sequence Number: 19189346
• Product Code: NBW
• UDI-Device Identifier: 00093815714118
• UDI-Public: (01)00093815714118(10)01Z232D
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/17/2026

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 Expiration Date: 07/31/2022
• Device Model Number: 71284-70
• Device Catalogue Number: 71284
• Device Lot Number: 8A63P0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 01/05/2022; 01/28/2026
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/10/2022; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• 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