MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MYO2 TINA-QUANT MYOGLOBIN GEN.2; MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 04580010190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer is questioning the results from 15 patient samples tested for myo2 tina-quant myoglobin gen.2 (myo2) on a cobas 6000 c (501) module compared to elecsys myoglobin immunoassay (myoglobin) results on a cobas e 411 immunoassay analyzer.Based on the data provided, the results for 5 patient samples were erroneous.It is not known if the comparison results were being used for diagnostic purposes.It is not known which results were believed to be correct.This information has been requested.The results from the e411 analyzer were not reported outside of the laboratory.It is not known if the results from the c501 were reported outside of the laboratory.No adverse event occurred.The c501 module serial number was not provided.The e411 analyzer serial number (b)(4).

Manufacturer Narrative

A specific root cause could not be identified.Additional information was requested for investigation but was not provided.Since no patient samples were available, the investigation could not be completed.No issues were identified during troubleshooting at the customer site.

• Brand Name: MYO2 TINA-QUANT MYOGLOBIN GEN.2
• Type of Device: MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM
• 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: 6221323
• MDR Text Key: 63826856
• Report Number: 1823260-2017-00008
• Device Sequence Number: 1
• Product Code: DDR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K061683
• 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
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04580010190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2016
• 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