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	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been 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 results from accuchek inform ii meter serial number (b)(6).At 5:24 a.M., the meter result was 186 mg/dl.At 7:17 a.M., the meter result was 148 mg/dl.At 7:54 a.M., the meter result was 426 mg/dl.At 7:56 a.M., the meter result was hi (>600 mg/dl).At 8:16 a.M., the meter result was 198 mg/dl using a new vial of testing strips.The result of 198 mg/dl was deemed correct.
Additional Manufacturer Narrative
Sections d9 and h3 were updated.The customer's strips were received for investigation.The strip vial, desiccant, and vial cap 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 product performed within specification.No product problem was identified.

• 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: 23909692
• Report Number: 1823260-2025-05359
• Device Sequence Number: 10024245
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/13/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 05942861001
• Device Lot Number: 671667
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/13/2026
• 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: DEXTROSE; DILAUDID; DULCOLAX EC; ESTRACE; FLOVRITE; GLUCAGON INJECTION; LEXAPRO; LIPITOR; LOVENOX; LYRICA; OPTIRAY 350; VANCOMYCIN; ZOFRAN
• Patient Age: 54 YR
• Patient Sex: Female