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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). The investigation could not identify a product problem. The cause of the event could not be determined. There was no remaining sample available for further investigation.
 
Event Description
The initial reporter stated they received discrepant thyroid test results for one patient sample tested on two cobas 8000 e 801 module analyzers, and a cobas e 411 immunoassay analyzer. The following assays were affected: elecsys ft3 iii, the elecsys tsh assay, and the elecsys tsh assay ver. 2. The values measured at the customer site were reported outside of the laboratory to a physician. This medwatch will apply to the tsh assay. Please refer to the medwatch with patient identifier: (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to tsh ver. 2. The sample was initially tested on the customer's e 801 analyzer on 13-oct-2020. At the customer site, the sample was also treated with polyethylene glycol (peg) and repeated on the customer's e 801 analyzer. The tsh ver. 2 assay was also repeated on the customer's e 801 analyzer after x2, x5, and x10 dilutions. The sample was repeated using the wako accuraseed and abbott architect methods. The sample was also provided for investigation, where it was tested for tsh, tsh ver. 2, and ft3 on a second e 801 analyzer used for investigation. During investigations, the sample was also tested for ft3 on an e411 analyzer. The serial number of the customer's e 801 analyzer is (b)(6). The serial number of the e 801 analyzer used for investigation is (b)(6). Tsh reagent lot number: 454296, with an expiration date of may 2021 was used on this analyzer.
 
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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 Key11045736
MDR Text Key241255080
Report Number1823260-2020-03307
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
Report Date 12/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number07028091190
Device Lot Number454296
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 Received12/01/2020
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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