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

Model Number CREP G2

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Calibration and qc were acceptable.The investigation did not identify a product problem.The assay is performing within specification.The cause of the event could not be determined.

Event Description

The initial reporter questioned high results using 1 particular reagent lot for 31 patient samples tested for creatinine plus ver.2 (crep2) on a cobas 8000 core unit.Of the data provided, the results for 1 patient sample were discrepant between 2 different reagent lots.Using reagent lot 499631, the result was 80 umol/l.Using reagent lot 484666 (expiration date not provided), the result was 66 umol/l.Questionable results were reported outside of the laboratory.The 8000 core unit serial number was (b)(4).

• Brand Name: CREATININE PLUS VER.2
• Type of Device: 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11156298
• MDR Text Key: 248358094
• Report Number: 1823260-2021-00127
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: CREP G2
• Device Catalogue Number: 05168589190
• Device Lot Number: 49963101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1