MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE; ENZYMATIC METHOD, CREATININE

Catalog Number 04810716190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received intermittent questionable creatinine jaffe gen.2 results from cobas c311 analyzer serial number (b)(4) when testing for albumin/creatinine ratio.Information was provided for four urine samples as the initial result undetectable (<1 mmol/l).When repeated, the result would still be undetectable.No specific data was provided.The customer alleges an issue with the results stating "it's almost impossible to have an undetectable creatinine given the fact that they're getting a result on microalbumin".The creatinine results were reported outside of the laboratory.There was no adverse event.

Manufacturer Narrative

As part of the investigation, the customer repeated the patient samples on cobas c502 and cobas c702 analyzers and the results were reproducible as undetected.

Manufacturer Narrative

A specific root cause could not be identified.Based on the provided information, a general reagent issue could be excluded.The customer believed the issue was due to the patient sample.Additional information was provided that the reagent used for the initial testing was actually creatinine enzymatic.

• Brand Name: CREATININE
• 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: 5436475
• MDR Text Key: 38228588
• Report Number: 1823260-2016-00159
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K941837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04810716190
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1