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

Catalog Number	05060303001
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable glucose result from the accu-chek inform ii meter + rf.Due to a display issue of a large black splotch in the upper left section, a result of 155 mg/dl was misinterpreted as 55 mg/dl.
Additional Manufacturer Narrative
The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.
Additional Manufacturer Narrative
Due to no product being returned, it was not possible to complete the investigation to exclude the device as the root cause.
Additional Manufacturer Narrative
Medwatch field d9 device available for evaluation, device returned to mfr, and date device returned were updated as the product was received for investigation.Medwatch field h3 device evaluated by mfg was updated as the product was received for investigation.The investigation determined that several black lines/spots were visible on the meter's display.The lines/spots may partially cover the result value.This is immediately visible to the user.The flaw is visible after turning on the device and permanently exists.There are no traces of an obvious mechanical impact visible on the housing of the device.The display assembly is found to be defective.Per product labeling, "if you notice any issues with the display functionality (e.G.Unexpected lines/marks on the meter display) stop using the system and contact the roche customer support center.".

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21535929
• Report Number: 1823260-2025-00650
• Device Sequence Number: 7735391
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/13/2026

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 Catalogue Number: 05060303001
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 01/26/2026
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/03/2025; 02/13/2026
• 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
• Patient Age: 51 YR
• Patient Sex: Female