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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 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter questioned results for 1 patient tested for elecsys pth stat immunoassay (pth stat) and elecsys ft4 iii (ft4 iii) on a cobas 6000 e 601 module. Based on the data provided, the results for ft4 iii, elecsys ft3 iii (ft3 iii) and elecsys tsh (tsh) were discrepant when compared to the abbott method. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results, medwatch with patient identifier (b)(6) for information on the pth stat results and medwatch with patient identifier (b)(6) for information on the ft3 iii results. The initial pth stat result from the e601 module was < 0. 127 pmol/l with a data flag. On (b)(6) 2019 the repeat result from the e601 module was < 0. 127 pmol/l with a data flag. The initial ft3 iii result from the e601 module was 26. 58 (unit of measure not provided). On (b)(6) 2019 the sample was repeated by the abbott method with a result of 4. 41 pmol/l. The initial tsh result from the e601 module was 0. 240 miu/l. On (b)(6) 2019 the sample was repeated by the abbott method with a result of 1. 76 uiu/ml on (b)(6) 2019 the initial ft4 iii result from the e601 module was > 100. 0 pmol/l with a data flag. On (b)(6) 2019 the repeat result from the abbott method was 14. 83 pmol/l. The initial results were reported outside of the laboratory. The customer suspects an interference in the patient sample affecting the results from the roche device. The e601 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 Key9612590
MDR Text Key217655386
Report Number1823260-2020-00174
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeTC
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 03/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue NumberASKU
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 Received01/02/2020
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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