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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGL TRIGLYCERIDES TRIGLYCERIDE TEST SYSTEM

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ROCHE DIAGNOSTICS TRIGL TRIGLYCERIDES TRIGLYCERIDE TEST SYSTEM Back to Search Results
Model Number TRIGL
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2020
Event Type  malfunction  
Event Description
The initial reporter questioned results for 1 patient sample that was highly lipemic tested for chol2 cholesterol gen. 2 (chol2) and trigl triglycerides (trigl) on a cobas 8000 c 502 module. The initial results for this sample were very high. The customer decided to ultracentrifuge the sample and discrepant results were generated for chol2 and trigl. This medwatch will cover trigl. Refer to medwatch with patient identifier (b)(6) for information on the chol2 results. The initial chol2 result was 381 mg/dl. The result after ultra-centrifuging was 173 mg/dl. The initial trigl result was 2553 mg/dl. The result after ultra-centrifuging was 1036 mg/dl. No questionable results were reported outside of the laboratory. The c502 module serial number was (b)(4).
 
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Brand NameTRIGL TRIGLYCERIDES
Type of DeviceTRIGLYCERIDE 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 Key9686247
MDR Text Key218258280
Report Number1823260-2020-00353
Device Sequence Number1
Product Code CDT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K873049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRIGL
Device Catalogue Number20767107322
Device Lot Number420284
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 Received01/17/2020
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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