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

Catalog Number	08057524190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with crep2 (creatinine) on a cobas pro c 503 analytical unit.No questionable results were reported outside of the laboratory.The sample initially resulted in a creatinine value of 0.156 mg/dl.As the result was not in line with the patient's clinical history, the sample was repeated.The repeat creatinine value was 1.42 mg/dl.The repeat value was considered correct.
Additional Manufacturer Narrative
Calibration data was ok.Quality controls recovered within range.A general reagent issue can be ruled out since calibration and controls are acceptable.Upon review of the alarm trace, an abnormal aspiration alarm occurred on (b)(6)2023 and on (b)(6)2023.The field application specialist checked pre-analytic sample handling at the site.Precision studies were performed and did not show any abnormalities.An interference due to the drugs cetuximab and encorafenib is unlikely since interference would also be shown in the repeat results of the sample.The investigation did not identify a product issue.The issue is consistent with incorrect pre-analytic sample handling or a single pipetting error.
Additional Manufacturer Narrative
The customer stated they received discrepant creatinine results for a second patient sample.This sample initially resulted in a creatinine value of 0.139 mg/dl on (b)(6) 2023 and it repeated as 0.996 mg/dl on (b)(6) 2023.For medwatch field d10, the customer confirmed the correct medications as cetuximab and encorafenib.D10 has been updated.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17962080
• Report Number: 1823260-2023-03344
• Device Sequence Number: 17840175
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 12/15/2023

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: 02/29/2024
• Device Catalogue Number: 08057524190
• Device Lot Number: 72953901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 12/14/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/27/2023; 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CETUCZIMAB/ENCO RAFEMIB; CETUXIMAB; ENCORAFENIB
• Patient Sex: Female