MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	05942861001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The accu-chek inform ii meter + rf serial number is (b)(6).The products have been requested for investigation but have not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.
Event or Problem Description
There was an allegation of questionable glucose results and error messages using the accu-chek inform ii test strips with the accu-chek inform ii meter + rf.Results were provided for one individual.The customer tested themselves to try to recreate the issue.The initial result at 18:55 was 152 mg/dl.The second result at 18:56 was 111 mg/dl.The same finger and fingerstick from the first result were used for the second result.
Additional Manufacturer Narrative
Medwatch field h6 type of investigation, investigation conclusion, and component code were updated.Medwatch field d9 is updated.The customer's meter and strips were received for investigation.All returned results are within the acceptable range.The log file did not indicate any hardware or software issues that would lead to a measurement discrepancy.The meter was disassembled for further investigation.No damage or contamination was observed.The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.Investigational testing was performed using glycolyzed blood.Analysis of the raw data was performed, and all results were acceptable.The alleged issue could not be reproduced.No product issue was found.

• Brand Name: ACCU-CHEK INFORM II TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24376240
• Report Number: 1823260-2026-00559
• Device Sequence Number: 17538838
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K121679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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 Catalogue Number: 05942861001
• Device Lot Number: 671892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female