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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 02/19/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). (b)(4).
 
Event Description
The initial reporter stated they received discrepant results for two patient samples tested with the elecsys tsh assay on a cobas 8000 e 801 module and a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer used for investigation. The second sample also had discrepant results for the elecsys ft4 iii assay when tested on the same analyzers. This medwatch will cover the tsh assay. Please refer to the medwatch with patient identifier (b)(4) for information related to the ft4 assay. Refer to the attachment for all patient data. Values highlighted in yellow are discrepant. The samples were initially tested on the e 801 analyzer at the customer site on (b)(6) 2020. The samples were repeated on a centaur analyzer. The samples were also provided for investigation where they were tested on a second e 801 analyzer, an e 602 analyzer, and an e411 analyzer on (b)(6) 2020. The serial number of the customer's e 801 analyzer is (b)(4). The serial number of the e 602 analyzer used for investigation is (b)(4). Tsh reagent lot number 429091, with an expiration date of 30-apr-2020 was used on this analyzer. The serial number of the e411 analyzer used for investigation is (b)(4). Tsh reagent lot number 429091, with an expiration date of 30-apr-2020 was used on this analyzer. The serial number of the e 801 analyzer used for investigation is (b)(4). Tsh reagent lot number 416233, with an expiration date of 31-oct-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 Key9859660
MDR Text Key220802925
Report Number1823260-2020-00788
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,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
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 Received02/28/2020
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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