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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 06/11/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). The e601 module serial number was (b)(4). The tsh reagent lot number used at the investigation site was 373386 with an expiration date of 30-jun-2019. From the data provided, a general reagent issue can be excluded. Assays from different manufacturers, in this case siemens, can generate different results. This relates to the overall setup of the assays, the antibodies used and differences in reference materials and standardization methodology. The investigation did not identify a product problem. The cause of the event could not be determined.
 
Event Description
The initial reporter complained of discrepant results for 2 patient samples tested for elecsys ft4 iii (ft4 iii) on a cobas e801 module. The 2 patient samples were submitted for investigation where additional discrepant results were identified for elecsys tsh (tsh) between the customer's e801 module, the centaur method and a cobas 6000 e 601 module used at the investigation site. Discrepant ft4 iii results were also identified between the customer's e801 module, the centaur method and a cobas e 411 immunoassay analyzer used at the investigation site. It is not known if any questionable results were reported outside of the laboratory. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results. There was no allegation that an adverse event occurred. The serial number for the customer's e801 module 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 Key8743725
MDR Text Key149497204
Report Number1823260-2019-02365
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 06/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2019
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2019
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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