MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS CREATININE PLUS VER.2 ASSAY; CREATININE TEST SYSTEM

Catalog Number	08057524190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6) the day after the repeat testing, the customer checked the sample that had been stored in the fridge.They found a slimy precipitate in the sample.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable cobas creatinine plus ver.2 assay results from the cobas c 503 analytical unit.The initial result was 22.1 mg/dl.On 01-sep-2024, the repeat result was 1.29 mg/dl.
Additional Manufacturer Narrative
The investigation found the event and the slimy precipitate in the sample were consistent with cryoglobulinemia.Cryoglobulinemia can significantly influence laboratory measurements and test results due to the unique properties of cryoglobulins.The investigation did not identify a product problem.

• Brand Name: COBAS CREATININE PLUS VER.2 ASSAY
• Common Device Name: CREATININE TEST SYSTEM
• 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: 20304847
• Report Number: 1823260-2024-02773
• Device Sequence Number: 7588472
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K024098
• 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): 12/27/2024

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: 08057524190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 12/27/2024
• 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 Sex: Unknown