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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS MYO2 TINA-QUANT MYOGLOBIN GEN.2 MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM Back to Search Results
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.
 
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Brand NameMYO2 TINA-QUANT MYOGLOBIN GEN.2
Type of DeviceMYOGLOBIN 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 Key6221323
MDR Text Key63826856
Report Number1823260-2017-00008
Device Sequence Number1
Product Code DDR
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K061683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04580010190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2016
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

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