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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
Catalog Number 05171407190
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2017
Event Type  malfunction  
Manufacturer Narrative
The customer has had no further issues since updating the application settings. The event was caused by user error as the customer did not update their application setting per product labeling.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer stated that they received erroneous results for two patient samples tested for triglycerides (trig) on a cobas 8000 c 702 module (c702). On (b)(6) 2017, the customer stated that both samples were tested within the past month, but could not provide details on exactly when they were tested. The date of event is not known. Both samples initially resulted with values that were approximately 240 mg/dl and these results were reported outside of the laboratory. The samples were diluted and repeated, with each resulting as approximately 4000 mg/dl. The patients were not adversely affected. The c702 analyzer serial (b)(4). When the customer's trig application settings were checked in the system software, it was determined that they were not using the current prozone limit settings for the trig application. The customer's trig prozone limit settings were updated and the test was re-calibrated.
 
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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 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 Key6824858
MDR Text Key119832446
Report Number1823260-2017-01835
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 Medical Technologist
Type of Report Initial,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05171407190
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 Received08/09/2017
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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