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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 Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2019
Event Type  malfunction  
Manufacturer Narrative
The serial number for the cobas e 801 used at the investigation site was (b)(4). The tsh reagent lot used on this cobas e 801 was 386646 with an expiration date of 31-may-2020. The ft4 ii reagent lot used on this cobas e 801 was 363195 with an expiration date of 31-dec-2019. The ft4 iii reagent lot used on this cobas e 801 was 380330 with an expiration date of 31-dec-2019. The ft3 iii reagent lot used on this cobas e 801 was 348359 with an expiration date of 31-oct-2019. The investigation is ongoing. The event occurred in (b)(6).
 
Event Description
The initial reporter complained of questionable thyroid results compared wako accuraseed for 1 patient sample tested on a cobas 8000 e 801 module. The patient sample was submitted for investigation. There were discrepant results identified for ft3 iii and tsh assays between the customer's e 801 module, an e 801 module used at the investigation site, and the wako accuraseed. There were discrepant results identified for ft4 iii on the customer's e 801 between elecsys ft4 ii assay on an e 801 module used at the investigation site and wako accuraseed. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft4ii results, medwatch with patient identifier (b)(6) for information on the ft4 iii results, and medwatch with patient identifier (b)(6) for information on the ft3 iii results. The results from the customer site were reported outside of the laboratory. Refer to the attachment to the medwatch for all patient data. The e 801 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 Key8920124
MDR Text Key178001705
Report Number1823260-2019-03068
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 10/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2019
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 Received08/06/2019
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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