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

Model Number CREP G2

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.There were no follow up/corrective actions.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Erroneous high results were generated by the cobas 6000 c (501) module.The event involved a total of 1 patient with the following: one erroneous result for crej2 creatinine jaffé gen.2.

Manufacturer Narrative

Correction for medwatch field b5.The following statement was reported on the previous medwatch: "the event involved a total of 1 patient with the following: one erroneous result for crej2 creatinine jaffé gen.2." this statement is updated to: "the event involved a total of 1 patient with the following: two erroneous results for crej2 creatinine jaffé gen.2.".

• Brand Name: CREATININE PLUS VER.2
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8544214
• MDR Text Key: 143408190
• Report Number: 1823260-2019-90100
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CREP G2
• Device Catalogue Number: 3263991190
• Device Lot Number: ASKU
• Patient Sequence Number: 1