MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK INFORM II INSTRUMENT WITH RF CARD; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number	05060303001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The strip lot number and expiration date were not provided.The product has been 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.
Event or Problem Description
There was an allegation of questionable results from accuchek inform ii meter, serial number (b)(6) , compared to a cobas c503 analyzer and an unknown blood gas analyzer.At 10:00 a.M., the meter result was 50.At 10:10 a.M., the meter result was 51.At 10:15 a.M., the meter result was 54.A sample was allegedly measured "immediately" on a cobas c503 analyzer and a blood gas analyzer.The cobas c503 analyzer glucose result was 693 and the blood gas analyzer result was 690.The units of measurement were not provided.
Additional Manufacturer Narrative
Sections d9 and h3 were updated.The meter was provided for investigation where they were tested using retention controls.Control ranges: level 1: 30-60 mg/dl, level 2: 261-353 mg/dl.Results: level 1: 43, 45, 43 mg/dl level 2: 297, 295, 291 mg/dl.All returned results are within acceptable range.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.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ACCU-CHEK INFORM II INSTRUMENT WITH RF CARD
• 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: 19927087
• Report Number: 1823260-2024-02285
• Device Sequence Number: 8375602
• Product Code: NBW
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: K012210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/02/2024
• 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: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian