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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
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ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM Back to Search Results
Catalog Number 08496609190
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2022
Event Type  malfunction  
Event Description
There was an allegation of questionable elecsys anti-tshr immunoassay results for 6 patient samples between 3 different reagent box numbers of the same lot on a cobas 8000 - cobas e 602 module.For patient 1, the anti-tshr result using box number:(b)(4) was 2.13.The result using box number: (b)(4) was 1.48.For patient 2, the anti-tshr result using box number: (b)(4) was 2.08.The result using box number: (b)(4) was 1.43.For patient 3, the anti-tshr result using box number: (b)(4) was 1.89.The result using box number: (b)(4) was 0.955.For patient 4, the anti-tshr result using box number: (b)(4) was 1.88.The result using box number: (b)(4) was 1.32.For patient 5, the anti-tshr result using box number: (b)(4) was 1.83.The result using box number: (b)(4) was 1.21.For patient 6, the anti-tshr result using box number: (b)(4) was 1.94.The result using box number: (b)(4) was 1.49.The units of measurement were requested but not provided.The initial results were reported outside of the laboratory.The analyzer serial number is (b)(4).
 
Manufacturer Narrative
The investigation is ongoing.
 
Manufacturer Narrative
Calibration and qc were acceptable.The investigation did not identify a product problem.The root cause of the event could not be determined.
 
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Brand Name
ELECSYS ANTI-TSHR
Type of Device
THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
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
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key15816553
MDR Text Key307699898
Report Number1823260-2022-03660
Device Sequence Number1
Product Code JZO
UDI-Device Identifier07613336160305
UDI-Public07613336160305
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K193313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Catalogue Number08496609190
Device Lot Number591690
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2022
Initial Date FDA Received11/17/2022
Supplement Dates Manufacturer Received12/09/2022
Supplement Dates FDA Received12/28/2022
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
Patient Sequence Number1
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