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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 06/14/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is currently ongoing. The event occurred in: (b)(6).
 
Event Description
The initial reporter complained of questionable thyroid results from a cobas 8000 e 801 module compared a wako accuraseed and an architect. Data that is a reportable malfunction for elecsys tsh assay, elecsys ft3 iii, elecsys ft4 iii assay, and elecsys ft4 ii assay for 1 patient was provided. This medwatch will cover tsh. For information ft3iii, ft4 iii, and ft4 ii refer to the medwatch with patient identifier's (b)(6) respectively. There was no allegation of an adverse event. The serial number for the cobas e801 used by the customer is (b)(4). The serial number for the cobas e801 used at the investigation site is (b)(4). The tsh reagent lot used on this instrument is 365417 with an expiration date of feb-2020. The ft4 ii reagent lot used on this instrument is 341695 with an expiration date of sep-2019. The ft4 iii reagent lot used on this instrument is 380330 with an expiration date of dec-2019. The ft3 iii reagent lot used on this instrument is 348359 with an expiration date of oct-2019.
 
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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 Key8758206
MDR Text Key150140606
Report Number1823260-2019-02431
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 09/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2019
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? No Answer Provided
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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