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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The test strip lot number is 671160.The expiration date was requested but not provided.The customer stated that the qc was performed on 16-oct-2024 at 4:29 am.The product was requested for investigation but has not been received.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.
Event or Problem Description
The initial reporter received questionable glucose results from one patient tested with the accu-chek inform ii meter.The first result at 7:37 am was 26.0 mmol/l.The second result at 7:38 am from the same site as the first result was 18.4 mmol/l.The third result at 7:39 am from the same site as the first result was 9.3 mmol/l.The result at 7:42 am was 6.8 mmol/l.
Additional Manufacturer Narrative
Medwatch fields d9 updated.The meter was received for investigation and was tested with retention strips and controls.Investigation results: qc ranges in mg/dl: level 1 - 30-60.Level 2 - 261-353.Meter results in mg/dl: level 1 ¿ 43, 42, 42.Level 2 ¿ 293, 291, 287.The meter results are within the acceptable range.The investigation found contamination within the meter's housing.The investigation did not identify a product problem.

• 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: 20749590
• Report Number: 1823260-2024-03382
• Device Sequence Number: 8756052
• Product Code: NBW
• UDI-Device Identifier: 04015630925469
• UDI-Public: 04015630925469
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 03/07/2025
• 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