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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 07/25/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation is currently ongoing. The event occurred in: (b)(6).
 
Event Description
The initial reporter complained of questionable thyroid results for 4 patients tested on a cobas 8000 e 801 module. From the data provided, 3 patients had discrepant results for elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii and 1 patient had discrepant results for ft4 iii and ft3 iii. The customer's cobas e801 data was compared to an investigation site's cobas 8000 e 801 module, cobas 8000 e 602 module, cobas e 411 immunoassay analyzer, and a centaur system. This medwatch with cover tsh. Refer to medwatch with patient identifier of (b)(6) for information on the ft4 iii results and to medwatch with patient identifier of (b)(6)for information on the ft3 iii results. It was unknown if the erroneous results were released outside of the laboratory. There was no allegation of an adverse event. The customer's cobas e801 serial number was requested but was not provided. The serial number for the cobas e602 used at the investigation site was (b)(4). The ft4 iii reagent lot used on this analyzer was 391521 with an expiration date of 29-feb-2020. The ft3 iii reagent lot used on this analyzer was 372451 with an expiration date of 30-nov-2019. The tsh reagent lot used on this analyzer was 394647 with an expiration date of 31-oct-2019. The serial number for the cobas e411 used at the investigation site was (b)(4). The ft4 iii reagent lot used on this analyzer was 378826 with an expiration date of 31-aug-2019. The ft3 iii reagent lot used on this analyzer was 372451 with an expiration date of 30-nov-2019. The tsh reagent lot used on this analyzer was 394647 with an expiration date of 31-oct-2019. The serial number for the cobas e801 used at the investigation site was (b)(4). The ft4 iii reagent lot used on this analyzer was 380330 with an expiration date of 31-dec-2019. The ft3 iii reagent lot used on this analyzer was 348359 with an expiration date of 31-oct-2019. The tsh reagent lot used on this analyzer was 386646 with an expiration date of 31-may-2020.
 
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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 Key8892519
MDR Text Key175216849
Report Number1823260-2019-02981
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 10/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2019
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 Received07/25/2019
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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