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

Catalog Number 03263991190

Device Problem High Test Results (2457)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

The cobas 8000 cobas c 502 module serial number was (b)(6).The investigation is ongoing.

Event 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.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18978772
• MDR Text Key: 338600141
• Report Number: 1823260-2024-00904
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03263991190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATENOLO; CANDESARTAN; CELLCEPT/MYFORTIC; COTRIM; COTRIMOXAZOLE; CYCLOSPORIN A; DEKRISTOL; MYCOPHENOLATE; PANTOZOL; PREDNISOLON; TESTIM