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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 High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). Quality control was acceptable on date of patient testing. The investigation is ongoing.
 
Event Description
The initial reporter questioned high elecsys tsh assay and elecsys ft4 iii assay results on a cobas 6000 e 601 module. The customer provided questioned results for one patient. The patient¿s initial tsh result was 6. 70 uiu/ml and ft4 result was 39. 8 pmol/l. The initial results were reported outside the laboratory. The physician questioned the results due to the results not fitting the patient¿s clinical picture. The customer performed repeat testing with another analyzer, abbott, and recovered a tsh result of 4. 41 mu/i and ft4 result of 20. 6 pmol/l. The repeat results were determined to be correct and reported outside the laboratory. Cobas 6000 e 601 module serial number used for patient testing was (b)(4). This medwatch is for tsh. Refer to the medwatch with patient identifier (b)(4) for the ft4 assay.
 
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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 Key9749816
MDR Text Key220297725
Report Number1823260-2020-00545
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeSZ
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 04/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberTSH
Device Catalogue Number08429324190
Device Lot Number42740101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
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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