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

Model Number CREP G2

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Event 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).

Manufacturer Narrative

Qc was acceptable.

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
• Type of Device: 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
• MDR Text Key: 316236638
• Report Number: 1823260-2023-01722
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATOVASTATIN; BISOPROLOL; CELLCEPT; CINACALCET; CLOPIDOGREL + ASPIRIN; CORTISONE; DOLUTEGRAVIR; DORAVIRINE; ESOMEPRAZOLE; IRBESARTAN; TACROLIMUS; VITAMIN D