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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGL TRIGLYCERIDES TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL

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ROCHE DIAGNOSTICS TRIGL TRIGLYCERIDES TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL Back to Search Results
Model Number TRIGL
Device Problem Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation for this event is ongoing. The follow up/corrective action for this event is not available. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
 
Event Description
This report summarizes 1 malfunction events. Non-reproducible results were generated by the cobas 8000 c 702 module for trigl triglycerides. The event involved a total of 1 patient.
 
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Brand NameTRIGL TRIGLYCERIDES
Type of DeviceTRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhofferstrasse 116
na
mannheim (baden-wurttemberg), na 68305
GM 68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key8549721
MDR Text Key143411804
Report Number1823260-2019-90128
Device Sequence Number1
Product Code CDT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberTRIGL
Device Lot Number328103
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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