ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO 06368590190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-15 for ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO 06368590190 manufactured by Roche Diagnostics.

Event Text Entries

[145101504] This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[145101505] The initial reporter complained of discrepant results for 2 patient samples tested for elecsys ft4 iii (ft4 iii), elecsys tsh (tsh) and elecsys anti-tpo (anti-tpo) on a cobas e801 module compared to the abbott architect method. This medwatch will cover anti-tpo. Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results and medwatch with patient identifier (b)(6) for information on the tsh results. The results from the e801 module were reported outside of the laboratory. The customer doesn't think the roche results are correct as they don't correspond to the patients' medical history or clinical picture. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4). The customer suspects an interference in the patient samples affecting the results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2019-01812
MDR Report Key8611212
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-05-15
Date of Report2019-07-25
Date of Event2019-04-01
Date Mfgr Received2019-04-24
Date Added to Maude2019-05-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
Generic NameSYSTEM, TEST, THYROID AUTOANTIBODY
Product CodeJZO
Date Received2019-05-15
Model NumberNA
Catalog Number06368590190
Lot Number36832100
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-15

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