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	01/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant glucose results for two patients tested with accu-chek inform ii meter serial number (b)(6).The customer has a policy of repeating testing if the meter result is > 400 mg/dl.A sample from the first patient was tested using the meter, resulting in a glucose value of "hi" (> 600 mg/dl).The test was repeated on the patient using the meter, resulting in a value of 218 mg/dl.Another measurement of the patient was performed using the patient's dexcom continuous glucose monitor and the result was 216 mg/dl.All measurements were performed within 15 minutes.The second result of 218 mg/dl was believed to be correct and the patient was treated based on that result.The customer did not know if different fingers were used to collect samples for each test.A sample from the second patient was tested using the meter, resulting in a glucose value of 461 mg/dl.Testing was repeated on the patient and the meter result was 253 mg/dl.All measurements were performed within 15 minutes.The second result of 253 mg/dl was believed to be correct and the patient was treated based on that result.The customer did not know if different fingers were used to collect samples for each test.
Additional Manufacturer Narrative
The customer's test strips were requested for investigation.The product has not been received at this time.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 results have passed the internal inspection.
Additional Manufacturer Narrative
No product was returned for investigation.The investigation did not identify a product issue.

• 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: 24731163
• Report Number: 1823260-2026-01162
• Device Sequence Number: 9287029
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/19/2026

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: 671701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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