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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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ROCHE DIAGNOSTICS ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Back to Search Results
Model Number TSH
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/25/2019
Event Type  malfunction  
Manufacturer Narrative
Calibration and controls on the analyzers used for investigation were ok. Assays from different vendors can generate different values. This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used. This event occurred in (b)(6).
 
Event Description
The initial reporter stated that they received discrepant results for two patient samples tested with the elecsys tsh assay on a cobas 8000 e 801 module and also a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer used for investigation. One of the two samples also had discrepant results for the elecsys ft4 iii assay. It was asked, but it is not known if any incorrect results were reported outside of the laboratory. This medwatch will apply to the tsh assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 iii assay. The samples were initially tested on the reporter's e 801 analyzer on (b)(6) 2019. The samples were repeated on a centaur analyzer. The samples were also provided for investigation, where they were tested on the second e 801 analyzer on (b)(6) 2019 and the e 602 and e411 analyzers on (b)(6) 2019. The serial number of the e 801 analyzer used at the reporter's site was (b)(4). The serial number of the e 602 analyzer used for investigation is (b)(4). Tsh reagent lot number 394674, with an expiration date of 31-oct-2019 was used on this analyzer. The serial number of the e411 analyzer used for investigation is (b)(4). Tsh reagent lot number 394674, with an expiration date of 31-oct-2019 was used on this analyzer. The serial number of the e 801 analyzer used for investigation is (b)(6). Tsh reagent lot number 386646, with an expiration date of 31-may-2020 was used on this analyzer.
 
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Brand NameELECSYS TSH ASSAY
Type of DeviceRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
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 Key8912136
MDR Text Key175720713
Report Number1823260-2019-03051
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K961491
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 08/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number07028091190
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 Received08/06/2019
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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