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

Catalog Number	05060303001
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated there are three issues with the software of accu-chek inform ii meter serial number (b)(6).Issue 1: the customer alleges that the meter is configured to use a valid patient id list and it is also configured to mask barcodes.The customer claims that the test strip vial was scanned by the meter in place of a patient id and a meter result could be obtained for a patient.The customer claims that the meter should not have allowed a patient result to be obtained with the current patient id masking configuration.Issue 2: the customer alleges that the meter allowed use of an operator id and it should not have allowed this due to the masking configuration on the meter.Issue 3: the customer alleges that the meter allowed patient testing between (b)(6) 2025 without requiring any controls.The last passing controls were run on (b)(6) 2025 for this meter.
Additional Manufacturer Narrative
The customer's meter was requested for investigation and replacement product was sent to the customer.The investigation is ongoing.
Additional Manufacturer Narrative
The accuchek strip vials use code-128.The customer's barcode type is unknown and no further information could be provided by the customer.According to the customer's allegation, their current mask "^2" means the id must start with a 2 and the 2 character will be kept.The minimum of 10 and the maximum of 14 for a 6 digit strip lot (lot 671447) should not be acceptable.It does not start with a '2' and is only 6 characters long.Further, the meters error log also does not show any logs of 'wrong barcode length'.A product problem can not be identified base on the available information.

• 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
• MDR Report Key: 23075792
• Report Number: 1823260-2025-03035
• Device Sequence Number: 4786046
• Product Code: LFR
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• 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): 12/18/2025

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: 12/04/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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 Sex: Unknown