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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 High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
This investigation is ongoing. This event occurred in (b)(6).
 
Event Description
The initial reporter received a questionable elecsys tsh assay result for one patient with the cobas e 801 module serial number (b)(4). Historically, the patient's tsh ran around 1 miu/ml with a normal ft4. Then in (b)(6) 2019, the patient's tsh was 95 miu/ml. A similar result was obtained in (b)(6) 2020. On (b)(6)2020 the initial result was 63. 4 miu/ml. The sample was tested with a 1:2 dilution with a result of 64. 6 miu/ml. The sample was tested with a 1:5 dilution with a result of 53. 4 miu/ml. The sample was tested with precipitation with scantibody tubes and the result was negative and polyethylglycol treatment was negative. Due to scantibody, the customer does not believe the high results are due to macro-tsh. The sample was also processed on a liaison analyzer with a result of 0. 65 miu/ml. The questionable result was reported outside the laboratory and questioned by the endocrinologist.
 
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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 Key11108612
MDR Text Key225291229
Report Number1823260-2021-00008
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeSP
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 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
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 Received12/11/2020
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 Invalid Data

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