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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 Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2017
Event Type  malfunction  
Manufacturer Narrative
The issue was resolved by updating the application parameters to the most current version. The issue was caused by user error, since the most recent application settings were not used.
 
Manufacturer Narrative
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
 
Event Description
The customer stated that they received an erroneous result for one patient sample tested for trigl triglycerides (trigl) on a cobas 8000 c 702 module (c702). The erroneous result was not reported outside of the laboratory. The sample initially resulted as 397 mg/dl. The sample was repeated on a second c702 analyzer, resulting as 1130 mg/dl accompanied by a data flag. The sample was repeated on the second c702 analyzer with a decreased sample volume, resulting as 3986 mg/dl. No adverse events were alleged to have occurred with the patient. According to product labeling, extremely lipemic samples can produce normal results. The customer was not using the most current version of the application parameters. In the most current test application version, the prozone check limit value was reduced in order to allow flagging of incorrect low triglyceride results of lipemic patient samples on the c702 analyzer. The customer has updated the application parameters to the most current version and have not experienced any further issues.
 
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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 Key6854629
MDR Text Key246818797
Report Number1823260-2017-01940
Device Sequence Number1
Product Code CDT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K873049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
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 Received09/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Catalogue Number05171407190
Device Lot Number238467
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 Received08/22/2017
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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