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

Model Number	CREP G2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for multiple patient samples tested with one specific crep2 (creatinine plus ver.2) reagent cassette on a cobas pro c 503 analytical unit, serial number (b)(4).The reporter mentioned quality control issues for the reagent cassette and subsequently, approximately 120 patient plasma and urine samples were measured.The reagent cassette was then replaced and the patient samples were repeated, showing about 30 % higher results.Of the data provided the following discrepant results for 5 patient plasma samples are representative examples.Patient sample 1 initially resulted in a crep2 value of 301 umol/l and repeated as 448 umol/l with the second reagent cassette.Patient sample 2 initially resulted in a crep2 value of 163 umol/l and repeated as 240 umol/l with the second reagent cassette.Patient sample 3 initially resulted in a crep2 value of 65 umol/l and repeated as 89.9 umol/l with the second reagent cassette.Patient sample 4 initially resulted in a crep2 value of 113 umol/l and repeated as 172 umol/l with the second reagent cassette.Patient sample 5 initially resulted in a crep2 value of 54 umol/l and repeated as 83.2 umol/l with the second reagent cassette.The questionable results were reported outside of the laboratory and corrected the same day.
Additional Manufacturer Narrative
Calibration signals were not as expected and show a shift in absorbance.This is an indicator of possible incorrect reconstitution of the calibrator.Quality control recovery showed a shift down within a short period of time on 17-mar-2023.Upon review of the alarm trace, sample "clot detection" and multiple "quality controls out of range" alarms were observed.The investigation could not identify a product problem.The issue is consistent with incorrect calibrator handling.

• 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: 16771582
• Report Number: 1823260-2023-01320
• Device Sequence Number: 19646303
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/12/2023

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: 03/22/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/12/2023
• 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