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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2 RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2 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 12/06/2019
Event Type  malfunction  
Manufacturer Narrative
The country of origin is (b)(6).
 
Event Description
The initial reporter received questionable tsh elecsys cobas e 200 v2, troponin t high sensitive, elecsys ft4 iii assay results from the cobas 8000 e 602 module serial number (b)(4). Each questionable test result was obtained from a different sample of the same premature neonate patient; the customer suspects biotin interference with each assay. This mdr will cover the tsh elecsys cobas e 200 v2 reagent. Refer to the mdr's with patient identifier
=
(b)(4) for the troponin t high sensitive reagent and (b)(4) for the elecsys ft4 iii assay reagent. For example, on (b)(6) 2019, a sample from the patient would recover a troponin t value of about 500 ng/l. After obtaining this value, the patient's doctor started the patient on a 10 mg/day biotin medication for treatment of metabolic diseases. On (b)(6) 2019, another sample from the patient would recover a troponin t value of < 7 ng/l. After treatment, the patient also recovered a tsh value of < 0. 005 uiu/ml on a different sample. On an unknown date after biotin treatment was started, another sample from the patient recovered a non-believable high ft4 value of >100 pmol/l. The questionable results were not reported outside the laboratory.
 
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Brand NameTSH ELECSYS COBAS E 200 V2
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 Key9602644
MDR Text Key219780641
Report Number1823260-2020-00164
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeFR
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 02/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number08429324190
Device Lot Number404125
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 Received12/20/2019
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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