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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGB TRIGLYCERIDES/GLYCEROL BLANKED LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

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ROCHE DIAGNOSTICS TRIGB TRIGLYCERIDES/GLYCEROL BLANKED LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES Back to Search Results
Catalog Number 05976006190
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/31/2018
Event Type  malfunction  
Event Description
The customer complained of low discrepant results for 3 patient samples tested for trigb triglycerides/glycerol blanked (trigb) on a cobas 8000 c 702 module. Patient 1 initial trigb result was 319 mg/dl. This result was reported outside of the laboratory where it was questioned by the doctor. On (b)(6) 2018 the sample was repeated and the result was 232 mg/dl with a data flag. The sample was repeated with auto-dilution and the result was 4121 mg/dl. On (b)(6) 2018 patient 2 (female, (b)(6)) initial trigb result was 558 mg/dl. This result was reported outside of the laboratory where it was questioned by the doctor. On (b)(6) 2018 the sample was repeated and the result was 514 mg/dl with a data flag. The sample was repeated with auto-dilution and the result was 3511 mg/dl. On (b)(6) 2018 patient 3 (female, (b)(6)) initial trigb result was 681 mg/dl. This result was reported outside of the laboratory where it was questioned by the doctor. The sample was repeated with auto-dilution and the result was 3337 mg/dl. The repeat results using auto-dilution were believed to be correct. No adverse event occurred. The c702 module serial number was (b)(4). The field service engineer (fse) visited the customer site and found the system was operating normally and there was no issue with the c702 module. The customer has not had any further events. The investigation did not identify a product problem. The cause of the event could not be determined.
 
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Brand NameTRIGB TRIGLYCERIDES/GLYCEROL BLANKED
Type of DeviceLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
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 Key7898155
MDR Text Key121583850
Report Number1823260-2018-03233
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
Report Date 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05976006190
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 Received09/04/2018
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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