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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 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
Unique identifier (udi)# (b)(4). The event occurred in: (b)(6).
 
Event Description
The customer complained of a questionable result for 1 patient tested for trigl triglycerides (trigl) on a cobas 8000 c (701) module. The initial trigl result was 182 mg/dl. The same sample was retested with a 1:20 dilution with a result of 10683 mg/dl. The erroneous result was released outside of the laboratory. There was no allegation of an adverse event. The trigl reagent lot was 25141601 with an expiration date of 30-jun-2018. The investigation is currently ongoing.
 
Manufacturer Narrative
Further analysis of the low trigl result of 182 mg/dl reaction monitor showed a reaction that indicated an oxygen depletion during the reaction. This low result should have been flagged with a data flag, but it was discovered by the field engineering specialist that the customer was not using the most current version of the trigl test application. Once the customer deleted the old test application version and installed the correct application version, the sample was retested and was correctly flagged by the analyzer.
 
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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
MDR Report Key7454646
MDR Text Key107092526
Report Number1823260-2018-01266
Device Sequence Number1
Product Code CDT
Combination Product (y/n)N
PMA/PMN Number
K873049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue Number05171407190
Device Lot Number25141601
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

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