MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA CREATININE PLUS VER.2 ASSAY; ENZYMATIC METHOD, CREATININE

Catalog Number	03263991190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine (crep gen.2) results from the cobas 8000 cobas c 502 module.The patient was a transplant patient and was regularly checked by his nephrologist who claimed the results were too high and did not fit the patient history and status.The customer questioned if there was an interference with the patient's medications.The creatinine result using the jaffe method in another laboratory was <100 ¿mol/l.The creatinine results using the enzymatic method were 223 ¿mol/l and 177 umol/l.The results were obtained with different samples from different venipunctures.
Additional Manufacturer Narrative
As no sample material was available, further investigation was not possible.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• Common Device Name: ENZYMATIC METHOD, CREATININE
• 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: 18978772
• Report Number: 1823260-2024-00904
• Device Sequence Number: 20457550
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• 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): 05/03/2024

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: 03263991190
• Device Lot Number: ASKU
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATENOLO; CANDESARTAN; CELLCEPT/MYFORTIC; COTRIM; COTRIMOXAZOLE; CYCLOSPORIN A; DEKRISTOL; MYCOPHENOLATE; PANTOZOL; PREDNISOLON; TESTIM
• Patient Sex: Unknown