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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 Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2019
Event Type  malfunction  
Manufacturer Narrative
The customer stated that they have seen this issue for a year. The customer believes the issue is resolved by either high centrifugation of the patient samples or letting the patient samples sit for greater than 24 hours. The customer considers the results obtained after performing these steps more consistent with the patient's clinical pictures and historical results. The investigation is currently ongoing. The event occurred in: (b)(6).
 
Event Description
The initial reporter complained of questionable results for multiple patients from two cobas 8000 c 702 modules and one cobas 6000 c (501) module. The customer believes that the patient's results are being affected by lipemia in the blood sample. From the data provided: 3 patients had questionable crej2 creatinine jaffé gen. 2, trigl triglycerides, and chol2 cholesterol gen. 2 results. 1 patient had questionable crej2 and trigl results. 6 patients had questionable crej2 results. 1 patient had questionable hdlc4 hdl-cholesterol plus 4th generation, trigl, and chol2 results. 2 patients had questionable trigl results. 5 patients had questionable trigl and chol2 results. The date of the event is the earliest known date that a questionable patient result was obtained. The customer indicated that this has been an ongoing issue. This medwatch will cover trigl. For crej2, hdlc4, and chol2 refer to the med watches with patient identifiers (b)(6) respectively. The customer verified that there was no allegation of any adverse events for any patients. The customer did not specify which results were from which analyzers. But they did provide the following instrument serial numbers: (b)(4).
 
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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 Key9075463
MDR Text Key218928584
Report Number1823260-2019-03317
Device Sequence Number1
Product Code CDT
Combination Product (y/n)N
Reporter Country CodeUK
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 03/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2019
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 Received08/23/2019
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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