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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 01/06/2021
Event Type  malfunction  
Manufacturer Narrative
The field service engineer determined the reagent pack was low. Sipper probes were adjusted. An instrument check was performed and was successful.
 
Event Description
The initial reporter stated they received discrepant results for three patient sample tested with the elecsys tsh assay on a cobas 8000 e 801 module. The initial values were reported outside of the laboratory. The samples were repeated and the repeat values were believed to be correct. The first sample initially resulted with a tsh value of 1. 58 uiu/ml, which repeated as 2. 71 uiu/ml. The second sample initially resulted with a tsh value of 3. 64 uiu/ml, which repeated as 7. 41 uiu/ml. The third sample initially resulted with a tsh value of 2. 67 uiu/ml, which repeated as 4. 15 uiu/ml. The serial number of the e 601 analyzer is (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 Key11169278
MDR Text Key226764920
Report Number1823260-2021-00168
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K961491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number08443432190
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 Received01/06/2021
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 Invalid Data

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