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

Model Number	CREP G2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated there were no issues with any other patient samples.The customer performed repeatability testing with other patient samples and the results were reproducible.The field service engineer (fse) completed instrument performance testing with acceptable results.It was noted that the "cleaner" bottle was empty.It is not known how long the bottle had been empty.Calibration was performed on (b)(6) 2023 and was acceptable.Qc was acceptable prior to the questionable result.No issues were identified during a review of the reaction monitor data."no fluid detected" and "clot detected" alarms were observed on the alarm trace data.As calibration and qc were acceptable, a general product problem can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for cobas integra creatinine plus ver.2 assay (crep2) on a cobas integra 400 plus.The initial result was 231 umol/l.This result was reported outside of the laboratory where it was questioned by the doctor.The repeat result was 84.4 umol/l.The integra 400 plus analyzer serial number was (b)(4).

• 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: 16454460
• Report Number: 1823260-2023-00610
• Device Sequence Number: 5860452
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K024098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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: 05/31/2023
• Device Model Number: CREP G2
• Device Catalogue Number: 03263991190
• Device Lot Number: 654879
• 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: 02/02/2023
• Initial Report FDA Received Date: 02/28/2023
• 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: 46 YR
• Patient Sex: Male