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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2 RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2 RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Back to Search Results
Model Number TSH
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2019
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 samples from the same patient tested with thyroid assays on the cobas 6000 e 601 module and a cobas 8000 e 602 module used for investigation. One sample labeled "sample 2" had discrepant values for elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay when tested on both systems. The other sample labeled "sample 1" had discrepant values for tsh and the elecsys tsh assay version 2 (tshv2) when tested on the e 602 system. The values measured at the customer site were reported outside of the laboratory to a physician. This medwatch will apply to the tshv2 assay. Please refer to the medwatch with patient identifier (b)(4) for information related to the tsh assay, refer to the medwatch with patient identifier (b)(4) for information related to the ft3 assay, and 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 erroneous. The sample labeled "sample 2" was measured at the customer site on (b)(6)2019. The sample labeled as "sample 1" was collected and tested on a different date at a different time, but this date/time is unknown. The samples were provided for investigation and tested on the e 602 analyzer. Tsh, ft3, and ft4 were tested on the e 602 for sample 2 on (b)(6) 2020. All testing for sample 1 was performed on the e 602 analyzer on (b)(6) 2020. For investigations, the sample was also tested with tsh on the e 602 analyzer before and after treatment with a heterophilic antibody blocking tube (hbt). The serial number of the customer's e 601 analyzer is (b)(4). The serial number of the e 602 analyzer used for investigation is (b)(4). Tshv2 reagent lot number 404125, with an expiration date of june 2020 was used on this analyzer.
 
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Brand NameTSH ELECSYS COBAS E 200 V2
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 Key9745831
MDR Text Key220297134
Report Number1823260-2020-00535
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,Followup
Report Date 04/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue NumberASKU
Device Lot Number404125
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 Received02/06/2020
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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