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

Model Number	CREP G2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned low results for 1 patient sample tested for crep2 creatinine plus ver.2 (crep2) on a cobas 6000 c (501) module.The initial result was 69 umol/l.The sample was repeated from the same tube with a result of 69 umol/l.A new sample was obtained "a few days later" and tested in another laboratory using an unknown method and the result was consistent with the patient¿s previous crep2 results between 262 umol/l and 288 umol/l.The specific result was not provided.The customer questions if any of the patient¿s medications could be interfering with the crep2 test.The c501 module serial number was (b)(6).
Additional Manufacturer Narrative
Qc was acceptable.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.As the creatinine calibration and qc data were acceptable, a general reagent issue could be excluded.A medication interference was excluded as all provided medications were given daily and the patient showed the expected results.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16987415
• Report Number: 1823260-2023-01722
• Device Sequence Number: 15166754
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/20/2023

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 Model Number: CREP G2
• Device Catalogue Number: 03263991190
• Device Lot Number: 706163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ATOVASTATIN; BISOPROLOL; CELLCEPT; CINACALCET; CLOPIDOGREL + ASPIRIN; CORTISONE; DOLUTEGRAVIR; DORAVIRINE; ESOMEPRAZOLE; IRBESARTAN; TACROLIMUS; VITAMIN D
• Patient Sex: Unknown