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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 06/14/2019
Event Type  malfunction  
Manufacturer Narrative
The event occurred in (b)(6). The investigation is ongoing.
 
Event Description
The initial reporter questioned thyroid results for 1 patient sample tested on a cobas 8000 e 801 module compared to an accuraseed analyzer. Based on the data provided, the elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii results were discrepant between the accuraseed analyzer and the customer's e 801 module. The customer questioned the anti-tshr results from the yamasa method. The sample was submitted for investigation where discrepant elecsys anti-tshr immunoassay results were identified between the yamasa method and an e801 module used at the investigation site. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft4iii results, medwatch with patient identifier (b)(6) for information on the ft3 iii results, and medwatch with patient identifier (b)(6) for information on the anti-tshr results. The initial results from the e 801 module were reported outside of the laboratory. There was no allegation that an adverse event occurred. The customer's e 801 module serial number was (b)(4).
 
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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 Key8776892
MDR Text Key150756009
Report Number1823260-2019-02501
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 09/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
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 Received06/15/2019
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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