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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 10/21/2017
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). (b)(4).
 
Event Description
The customer stated that they received an erroneous results for one severely lipemic patient sample tested for trigl triglycerides (trig) on a cobas 8000 c 702 module (c702). The erroneous result was not reported outside of the laboratory. The sample initially resulted as 173. 3 mg/dl. The sample was automatically diluted 1:50 and repeated on a different analyzer, resulting as 6863. 7 mg/dl. No adverse events were alleged to have occurred with the patient. The c702 analyzer serial number was asked for, but not provided. The reaction monitor of the first result showed a strong decrease in absorbance due to oxygen depletion during the assay reaction. It was confirmed that 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. Upon review of calibration data, the last valid 2 point calibration was performed on (b)(6) 2017. From (b)(6) 2017 to (b)(6) 2017, successful blank calibrations were performed. Data was provided for one level of quality control and this was within range on the day of the event. Upon review of the alarm trace, several abnormal aspiration and sample short alarms could be observed from (b)(6) 2017 to (b)(6) 2017. The root cause is most likely related to the test application not being updated to the most current version. Based on the alarms received, a pre-analytic sample handling issue may also be a possible root cause.
 
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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 Key7009778
MDR Text Key92609314
Report Number1823260-2017-02557
Device Sequence Number1
Product Code CDT
Combination Product (y/n)N
Reporter Country CodeEG
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
Report Date 11/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2017
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 Number23846701
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 Received10/23/2017
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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