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

Catalog Number 08057524190

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 326308467
• Report Number: 1823260-2023-03344
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K812095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/31/2023; 12/14/2023
• Supplement Dates FDA Received: 11/27/2023; 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CETUCZIMAB/ENCO RAFEMIB; CETUXIMAB; ENCORAFENIB
• Patient Sex: Female