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	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter a serial number was (b)(6).Meter b serial number was (b)(6).Controls were run on both meters with results within range.The test strips were requested for investigation.On a regular basis, inform strips of lots currently valid in the market are tested as part of routine retention testing, and the results have passed the internal inspection.The test strips were received for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant glucose results for 1 patient tested on 2 accu-chek inform ii meters with serial numbers (b)(6) (meter a) and (b)(6) (meter b).Meter a was also discrepant with the laboratory.At 10:04 p.M., the result from meter a was 35 mg/dl.The result at 10:10 p.M.Was 37 mg/dl.At 10:19 p.M., the result from the laboratory was 121 mg/dl.At 10:40 p.M., the result from meter a was 59 mg/dl.At 10:46 p.M., the result from meter b was 83 mg/dl.
Additional Manufacturer Narrative
Two vials of test strips with lot 671669 were submitted for investigation.The strip vials, desiccants, and vial caps were inspected and were acceptable in appearance.Testing was performed using glycolyzed blood with the returned strips.All testing produced acceptable results, and no strip defects were observed.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 23942638
• Report Number: 1823260-2026-00001
• Device Sequence Number: 13451486
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/18/2026

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: 671669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/18/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; ELIQUIS; OSCAL; PEPCID; REFRESH PLUS; ROCEPHIN; ZEBETA
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 68 KG