MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2; ENZYMATIC METHOD, CREATININE

Catalog Number	05168589190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient urine sample tested for crep2 creatinine plus ver.2 (crep2) on a cobas 8000 c 702 module.The initial result from the c702 module was 155.58 mg/dl.The same sample was also sent to another laboratory where the result was 306.21 mg/dl.The initial result from the c702 module was reported outside of the laboratory where it was questioned by the nurse.The customer repeated the sample twice on the c702 module with results of approximately 300 mg/dl.An aliquot from the sample sent to the other laboratory was also repeated twice with results of approximately 300 mg/dl.The result of 306.21 mg/dl and the repeat results of approximately 300 mg/dl were believed to be correct.
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023 with acceptable results.Qc was acceptable.The field service engineer (fse) did not find a cause for the issue.The fse inspected the instrument and verified the sample probe adjustments were within specification.The customer performed successful qc.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CREP2
• 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: 17643784
• Report Number: 1823260-2023-02812
• Device Sequence Number: 7585725
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 05168589190
• Device Lot Number: 70264101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/07/2023
• 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
• Patient Age: 51 YR
• Patient Sex: Male