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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 01/13/2021
Event Type  malfunction  
Manufacturer Narrative
The calibration and qc data were requested but not provided. The investigation did not identify a product problem. The cause of the event could not be determined. Assays from different vendors can generate different values. This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used. This event occurred in (b)(6). D4 unique identifier (udi) #: (b)(4).
 
Event Description
The initial reporter received questionable elecsys tsh assay and elecsys ft4 iii assay results for one patient with the cobas e 801 module serial number (b)(4). The customer reported the tsh results to a physician who asked for a re-measurement of the samples. The samples were sent for an investigation and were tested on a cobas e801 module, cobas e602 module, cobas e 411 immunoassay analyzer, and a siemens centaur analyzer. The investigation site e801 module serial number was (b)(4). The e602 module serial number was (b)(4). The e411 serial number was (b)(4). The tsh reagent lot number and expiration date used at the investigation site were requested but not provided. Refer to the attachment on the medwatch for all patient data. This medwatch is for tsh. Refer to the medwatch with a1 patient identifier (b)(6) for the ft4 assay.
 
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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 Key11354486
MDR Text Key243210864
Report Number1823260-2021-00524
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 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2021
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 Received01/28/2021
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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