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	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's test strips were requested for investigation.The product has 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 for two patients tested with accu-chek inform ii meter serial number: (b)(6).Patient 1: on (b)(6) 2026, at 10:18, the meter result was 521 mg/dl.At 10:20, the meter result was 285 mg/dl.This result was believed to be correct.At 10:21, the meter result was 277 mg/dl.Patient 2: on (b)(6) 2026, at 23:32, the meter result was "hi" (represented as 601 mg/dl).At 23:34, the meter result was 149 mg/dl.This result was believed to be correct.On (b)(6) 2026, at 4:32, the laboratory result was 117 mg/dl.The customer did not know if different fingers were used to collect samples for each test.The customer has a policy of repeating testing if the meter result is > 400 mg/dl.

• 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: 24764372
• Report Number: 1823260-2026-01231
• Device Sequence Number: 10157293
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 04/02/2026

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: 671890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/02/2026
• 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: PATIENT 1: CEFTRIAZONE.; PATIENT 1: DULCOLAX.; PATIENT 1: GABAPENTIN.; PATIENT 1: HEPARIN.; PATIENT 1: INSULIN.; PATIENT 1: LANTUS.; PATIENT 1: LASIX.; PATIENT 1: LIPITOR.; PATIENT 1: LOPRESSOR.; PATIENT 1: MAGNESIUM SULFATE.; PATIENT 1: MIRALAX.; PATIENT 1: NORVASC.; PATIENT 1: OXYCODONE.; PATIENT 1: POTASSIUM CHLORIDE.; PATIENT 1: PYRIDIUM.; PATIENT 1: SALINE.; PATIENT 1: SUBLIMAZE.; PATIENT 1: SYNTHROID.; PATIENT 1: TOPROL XL.; PATIENT 1: TORADOL.; PATIENT 1: TYLENOL.; PATIENT 1: VESICARE.; PATIENT 1: VITAMIN B1.; PATIENT 1: XARELTO.; PATIENT 1: ZESTRIL.; PATIENT 1: ZOFRAN.; PATIENT 2: AMLODIPINE BESYLATE.; PATIENT 2: ASPIRIN.; PATIENT 2: ATORVASTATIN CALCIUM.; PATIENT 2: BUSPIRONE HCL ACID.; PATIENT 2: FERROUS SULFATE.; PATIENT 2: FUROSEMIDE.; PATIENT 2: GABAPENTIN.; PATIENT 2: LEVOTHYROXINE SODIUM.; PATIENT 2: LISINOPRIL.; PATIENT 2: OMEPRAZOLE.; PATIENT 2: POTASSIUM CHLORIDE.; PATIENT 2: QUETIAPINE FUMARATE.; PATIENT 2: SITAGLIPTIN PHOS/METFORMIN HCL.; PATIENT 2: TYLENOL.; PATIENT 2: VENLAFAXINE HCL.
• Patient Age: 79 YR
• Patient Sex: Female