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

Model Number	CREP G2
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with crep2 creatinine plus ver.2 on a cobas 6000 c (501) module (serial number (b)(4)).It was asked, but it is not known if any questionable results were reported outside of the laboratory.The first sample initially resulted in a creatinine value of 199.7 umol/l when tested on a siemens analyzer.The sample was repeated with the roche creatinine method on the c 501 analyzer, resulting in a value of 99 umol/l.The second sample initially resulted in a creatinine value of 205.0 umol/l when tested on a siemens analyzer.The sample was repeated with the roche creatinine method on the c 501 analyzer, resulting in a value of 99 umol/l.
Additional Manufacturer Narrative
Both samples were collected from the same patient.Medwatch field d10 has been updated.
Additional Manufacturer Narrative
The investigation determined the results from the roche analyzer are plausible.The investigation could not identify a product problem.
Additional Manufacturer Narrative
Two patient samples were provided for investigation.The customer's c501 creatinine results were able to be reproduced during the investigation.It was determined that there was no bromelain interference in the patient sample.The investigation is ongoing.

• 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: 16555782
• Report Number: 1823260-2023-00841
• Device Sequence Number: 20068017
• 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,Followup,Followup
• Report Date (Section B): 06/30/2023

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
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 05/16/2023; 06/06/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/25/2023; 06/09/2023; 06/30/2023
• 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: ACID HYALURONIQUE; ALPHA 2 MICROGLOBULIN; BROMELAIN (FOR JOINT PAIN); GHB; METHOTREXATE; TEICOPLANIN
• Patient Sex: Unknown