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	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An allegation of questionable blood glucose results was received for a single patient tested consecutively on an accu-chek inform ii meter + rf meter.Testing performed within 15 minutes yielded 323 mg/dl and 145 mg/dl.The lower result was deemed correct.
Additional Manufacturer Narrative
The accu-chek inform ii meter + rf meter serial number is (b)(6).The customer stated that the qcs were acceptable within 24 hours of the event.The meter and test strips were requested for investigation, but have not been received.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 the results have passed internal inspection.

• 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 -045
• 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: 50865753
• Report Number: 1823260-2026-03899
• Device Sequence Number: 10715538
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 480842
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• 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: Unknown