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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 Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
Event Type  malfunction  
Manufacturer Narrative
There was no remaining volume of the patient sample available for further investigation. The investigation could not identify a product problem. The cause of the event could not be determined. This event occurred in (b)(6).
 
Event Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay and elecsys ft3 iii on a cobas 8000 e 801 module. The sample also had discrepant tsh and ft3 results when tested on a cobas e 411 immunoassay analyzer, a cobas 8000 e 602 module, and a second e 801 analyzer used for investigation. The measurements obtained at the customer site were reported outside of the laboratory to a physician. This medwatch will apply to the tsh assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay. The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020. The sample was repeated on a centaur analyzer. The sample was provided for investigation, where it was tested on the e411, e 602, and second e 801 analyzer on (b)(6) 2020. The e 801 analyzer used at the customer site is serial number (b)(4). The e 602 analyzer used for investigation is serial number (b)(4). Tsh reagent lot number 429091, with expiration date of 30-apr-2020 was used on this analyzer. The e411 analyzer used for investigation is serial number (b)(4). Tsh reagent lot number 347456, with expiration date of 01-sep-2020 was used on this analyzer. The e 801 analyzer used for investigation is serial number (b)(4). Tsh reagent lot number 416233, with 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 Key9811882
MDR Text Key216110159
Report Number1823260-2020-00696
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 03/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2020
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 Received02/20/2020
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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