MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II METER + RF; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number	05060303001
Medical Device Problem Codes	Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The accu-chek inform ii test strips lot number is (b)(6).The customer reported that the qc check passed on the date of the event.The product has been requested for investigation, but has not yet been received.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable glucose result with accu-chek inform ii test strips from the accu-chek inform ii meter + rf for one patient.The initial result at 10:04 p.M.Was 135 mg/dl.A venous sample from 11:10 p.M.Had a result of 119 mg/dl.The second result at 11:24 p.M.Was "hi".The third result at 11:26 p.M.Was 540 mg/dl.The fourth result at 11:30 p.M.Was 155 mg/dl.The patient was receiving a glucose iv, and the results of "hi" and 540 mg/dl were from samples collected from the fingertips of the arm with the iv.The result of 155 mg/dl was believed to be correct.There was no treatment received based on the questionable results.
Additional Manufacturer Narrative
Medwatch field h3: device evaluated by mfg updated.The customer's returned meter was tested with retention strips and retention controls for investigation with the following results.Control ranges: level 1: 30-60 mg/dl.Level 2: 261-353 mg/dl.Results: level 1 ¿ 44, 45, and 43 mg/dl.Level 2 ¿ 302, 306, and 302 mg/dl.All of the results are within an acceptable range.The allegation in this case could not be substantiated; therefore, no product issue was found.

• Brand Name: ACCU-CHEK INFORM II METER + RF
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• 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 46250-0457
• MDR Report Key: 23075935
• Report Number: 1823260-2025-03037
• Device Sequence Number: 18658104
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/17/2025

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: 05060303001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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 Age: 73 YR
• Patient Sex: Unknown