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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 02/20/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). The e602 module serial number was (b)(4). The e411 analyzer serial number was (b)(4). The e801 module serial number used at the investigation site was (b)(4). The tsh reagent lot number used with the e602 module and e411 analyzer was 394647 with an expiration date of oct-2019. The tsh reagent lot number used with the e801 module at the investigation site was 365417 with an expiration date of feb-2020.
 
Event Description
The initial reporter questioned thyroid results for 1 patient sample tested for elecsys ft3 iii (ft3 iii), elecsys tsh (tsh), and elecsys ft4 iii (ft4 iii) between a cobas e 801 module and the accuraseed method. The customer's results were reported outside of the laboratory. The patient sample was submitted for investigation where discrepant results were identified for ft3 iii, tsh, ft4 iii and ft4 ii between the customer's e801 module, the architect method, the accuraseed method, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site. 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 ft3 iii erroneous results and medwatch with patient identifier (b)(6) for information on the ft4 ii results. There was no allegation that an adverse event occurred. The serial number for the customer's e801 module was (b)(4).
 
Manufacturer Narrative
Sample from the patient was provided for further investigation. Further investigation of the sample confirmed the sample contained an immunoglobulin that reacts with the reagent which affects the sample results. This is covered in product labeling.
 
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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
MDR Report Key8780079
MDR Text Key150759961
Report Number1823260-2019-02519
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
PMA/PMN Number
K961491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/11/2019 Patient Sequence Number: 1
Treatment
THYRADIN; THYRADIN
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