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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 08/07/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). (b)(4).
 
Event Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, the elecsys ft4 iii assay, and elecsys cortisol ii on a cobas 8000 e 602 module. The sample also had a discrepant result for the elecsys ft4 ii assay when tested on an elecsys analyzer used for investigation. No incorrect results were reported outside of the laboratory. It was not clear if the elecsys analyzer used for investigation was a cobas 8000 e 602 module or if it was a cobas 8000 e 801 module. A clarification has been requested. 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, refer to the medwatch with patient identifier (b)(6) for information related to the ft4iii assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft4ii assay, and refer to the medwatch with patient identifier (b)(6) for information related to the cortisol assay. The sample was initially tested on the customer¿s e 602 analyzer on (b)(6) 2019. The sample was provided for investigation where it was repeated on an elecsys analyzer on 09-aug-2019. The sample was also repeated on an abbott architect analyzer. The serial number of the customer's e 602 analyzer is (b)(4). The serial number of the elecsys analyzer used for investigation is (b)(4). Tsh reagent lot number 402248, with an expiration date of november 2019 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 Key8961149
MDR Text Key212311803
Report Number1823260-2019-03209
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
Type of Report Initial,Followup,Followup,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number11731459122
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 Received08/13/2019
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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