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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 Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation could 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). (b)(4).
 
Event Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module and a second e 801 analyzer used for investigation. This medwatch will apply to the tsh assay. Please refer to the medwatch with patient identifier (b)(4) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(4) for information related to the ft4 assay. Refer to the attachment for all patient data. The sample was collected on (b)(6) 2020 and was tested at the customer site either on (b)(6) 2019. The customer measured the sample on the e 801 analyzer and using the wako accursed method. The customer also tested tsh on the e 801 analyzer after diluting the sample x2, x5, and x10. The customer also treated the sample with polyethylene glycol (peg) and tested the sample on the e 801 analyzer. The sample was repeated on an abbott architect analyzer. The sample was also provided for investigation where it was tested on a second e 801 analyzer on (b)(6) 2020. The serial number of the customer's e 801 analyzer is (b)(4). The e 801 analyzer used for investigation is serial number (b)(4). Tsh reagent lot number 416233, with an expiration date of october 2020 was used on this analyzer.
 
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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 Key9705856
MDR Text Key220044841
Report Number1823260-2020-00428
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
Report Date 02/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2020
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 Received01/27/2020
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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