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

Catalog Number	05942861001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inform ii meter serial number was (b)(6).Both levels of qc were acceptable within 24 hours of the event.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 results have passed the internal inspection.
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient tested on an accu-chek inform ii meter + rf compared to the laboratory.At 7:48 a.M., the result from the meter from a finger stick was > 600 mg/dl.At 7:50 a.M., the result from the meter using a different finger stick was > 600 mg/dl.A sample was drawn for the laboratory at 8:03 a.M.With a result of 83 mg/dl.The result from the laboratory was believed to be correct.The patient was asymptomatic.
Additional Manufacturer Narrative
The customer did not return the test strips for investigation.As no product was returned, a specific root cause 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: 24529585
• Report Number: 1823260-2026-00794
• Device Sequence Number: 18726370
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/16/2026

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: 671701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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: CELEXA; DEXTROSE 50% - AS NEEDED; FOLIC ACID; GLUCAGEN INJECTION - AS NEEDED; HEPARIN 5000 UNITS - EVERY 8 HRS; IMDUR; LACIX; LANTUS INSULIN - NIGHTLY; LIPITOR; LISPRO INSULIN - AS NEEDED AND BEFORE MEALS; MEDROL; REQUIP; ROBAXIN; SODIUM BICARB - 2X/DAY; WELLBUTRIN
• Patient Age: 81 YR
• Patient Sex: Female