MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2; CREATININE TEST SYSTEM

Model Number	CREP G2
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration data from the day of the event was not provided.Qc was acceptable.Precision data suggest issues with cell rinse functionality.The field service engineer (fse) checked the instrument and sample probe.No issues were identified.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two samples collected on the same day from one patient and tested with the crep2 (creatinine plus ver.2) assay on a cobas pro c 503 analytical unit, serial number (b)(4).First patient sample, tested out of a primary tube: the sample initially resulted in a crep2 value of 30.7 mg/l.On (b)(6)2023, the sample was repeated two times, resulting in crep2 values of 19.2 mg/l and 19.4 mg/l.Second patient sample, tested out of a secondary tube: the sample initially resulted in a crep2 value of 9.05 mg/l and repeated as 8.8 mg/l.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
A general reagent issue has been excluded as qc was acceptable.Based on the data provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: CREP2
• Common Device Name: CREATININE TEST SYSTEM
• 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: 16835214
• Report Number: 1823260-2023-01431
• Device Sequence Number: 12646522
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K812095
• 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
• Report Date (Section B): 05/18/2023

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: 08/31/2023
• Device Model Number: CREP G2
• Device Catalogue Number: 08057524190
• Device Lot Number: 69245901
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/18/2023
• 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 Sex: Unknown