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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 06/07/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). The e801 module used at the investigation site was (b)(4). The tsh reagent lot number used at the investigation site was 386646 with an expiration date of may-2020. Calibration and qc at the investigation site were acceptable. The sample was requested for investigation but could not be provided. Since the sample could not be provided, the investigation could not be completed. From the data provided, a general reagent issue can be excluded. Assays from different manufacturers, in this case abbott, 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 1 patient sample tested for elecsys tsh (tsh) and elecsys ft3 iii (ft3 iii) on a cobas e 801 module compared to the accuraseed method. It is not known if any questionable results were reported outside of the laboratory. The sample was submitted for investigation where discrepant results were identified for elecsys ft4 iii (ft4 iii) between the e801 module used at the investigation site and the architect method, discrepant tsh results were identified between the customer's e801 module and the e801 module at the investigation site and discrepant ft3 iii results were identified between the customer's e801 module, the architect method and the e801 module used at the investigation site. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the ft4 iii results. There was no allegation that an adverse event occurred. The customer's e801 module 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 Key8735846
MDR Text Key149380879
Report Number1823260-2019-02324
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 06/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2019
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 Received06/07/2019
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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