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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
Catalog Number 08429324190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is currently ongoing. The event occurred in: (b)(6).
 
Event Description
The initial reporter complained of questionable elecsys tsh assay and elecsys ft4 iii assay results for 1 patient tested on a cobas 8000 e 602 module compared to an abbott. This medwatch will cover tsh. For information on ft4 iii please refer to the medwatch with patient identifier (b)(6). The cobas e602 results were tsh 7. 02 u/l and ft4 iii 88. 8 pmol/l the abbott results from the same patient sample were tsh 4. 37 (units not provided) and ft4 38. 6 pmol/l. The results in question were reported outside of the laboratory. The cobas e602 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 Key8906051
MDR Text Key175716625
Report Number1823260-2019-03031
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeBE
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 09/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number08429324190
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 Received08/01/2019
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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