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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY
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ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY Back to Search Results
Catalog Number 06368590190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).The e601 module serial number used at the investigation site was (b)(4).
 
Event Description
The initial reporter questioned thyroid results for 1 patient sample tested on a cobas 8000 e 602 module.The patient sample was submitted for investigation where discrepant results were identified for elecsys ft4 iii (ft4 iii), elecsys tsh assay (tsh), elecsys ft4 ii (ft4 ii), elecsys ft3 iii (ft3 iii), elecsys anti-tshr immunoassay (anti-tshr) and elecsys anti-tpo (anti-tpo) between the customer's e602 module, the architect method, the yamasa method, and an e601 module used at the investigation site.It is not known if any questionable results were reported outside of the laboratory.This medwatch will cover anti-tpo.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 tsh results, medwatch with patient identifier (b)(6) for information on the ft4 ii results, medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the anti-tshr results.There was no allegation that an adverse event occurred.The customer's e602 module serial number was (b)(4).
 
Manufacturer Narrative
The customer returned two samples for investigation.The anti-tpo results were measured above the reference range.An interfering factor against streptavidin could be identified.This type of interfering factor is addressed in the product labeling.The investigation did not identify a product problem.
 
Manufacturer Narrative
Relevant tests,laboratory data was updated.
 
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Brand Name
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
Type of Device
SYSTEM, TEST, THYROID AUTOANTIBODY
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key8686253
MDR Text Key147612187
Report Number1823260-2019-02140
Device Sequence Number1
Product Code JZO
Combination Product (y/n)N
PMA/PMN Number
K051890
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2019
Device Catalogue Number06368590190
Device Lot Number368321
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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