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	11/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One accu-chek inform ii meter + rf serial number was provided as (b)(6).The other meter serial number is unknown.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 the internal inspection.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.
Event or Problem Description
There was an allegation of a questionable glucose result using the accu-chek inform ii test strips with the accu-chek inform ii meter + rf for one patient.The initial result at 12:05 am was 365 mg/dl.The result at 12:07 am on an unknown meter was 174 mg/dl.The result of 174 mg/dl is believed to be correct.
Additional Manufacturer Narrative
The requested product was not returned, so a substantial investigation could not be carried out.Therefore, there was no product issue found.No information was provided in the complaint case that would point to a cause for the result discrepancy.
Additional Manufacturer Narrative
Medwatch field d device other infor was updated.Medwatch h6 medical device problem code, type of investigation, and investigation conclusion were updated.The customer's strips were returned for investigation.The customer's meter was not returned for investigation.The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.Investigational testing was performed using glycolyzed blood.All testing with the returned strips produced acceptable results, and no questionable results were observed.The alleged issue could not be reproduced.The investigation determined that no product issue was found.

• 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: 23863145
• Report Number: 1823260-2025-05268
• Device Sequence Number: 21184482
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 03/25/2026

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 03/06/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/04/2026; 03/25/2026
• 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