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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 03/15/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). The e801 module serial number 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.
 
Event Description
The initial reporter complained of discrepant results for 1 patient sample from (b)(6) 2019 for elecsys ft4 iii (ft4 iii), elecsys tsh (tsh) and elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to the accuraseed method. The initial results from the customer site were not reported outside of the laboratory. There was an insufficient amount of this sample material remaining so the investigation and outsourced laboratory using the architect method tested a sample from the same patient from (b)(6) 2019. Discrepant results were identified between the customer's e801 module, the e801 module used at the investigation site and the architect method. It is not known if the results from (b)(6) 2019 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 and medwatch with patient identifier (b)(6) for information on the ft3 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 Key8722574
MDR Text Key149090759
Report Number1823260-2019-02273
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 08/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2019
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 Received05/30/2019
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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