ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

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 2019-02-08 for ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO manufactured by Roche Diagnostics.

Event Text Entries

[135719711] This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[135719712] The customer stated that they received erroneous results for one patient sample tested with the elecsys ft4 iii assay and roche diagnostics cobas elecsys anti-tpo on a cobas 6000 e 601 module. The same sample also had an erroneous result for the elecsys anti-tshr immunoassay on a cobas e 411 immunoassay analyzer. The erroneous values were reported outside of the laboratory and did not match the patient's clinical condition. This medwatch will apply to the anti-tpo assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay and refer to the medwatch with patient identifier (b)(6) for information related to the anti-tshr assay. The sample was tested on the e 601 analyzer on (b)(6) 2019, resulting with a ft4 value of 31. 38 pmol/l and an anti-tpo value of 531 iu/ml. The sample was tested on the e 411 analyzer on (b)(6) 2019, resulting with an anti-tshr value of 6. 38 iu/l. The results from the roche analyzers did not agree with the clinical picture of the patient as the patient had a previous sample tested at another laboratory using the diasorin method and results were different. No adverse events were alleged to have occurred with the patient. The serial number of the customer's e 601 analyzer is (b)(4). The serial number of the customer's e411 analyzer was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2019-00527
MDR Report Key8320958
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-02-08
Date of Report2019-04-15
Date of Event2019-01-17
Date Mfgr Received2019-01-25
Date Added to Maude2019-02-08
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 Received2019-02-08
Model NumberNA
Catalog NumberASKU
Lot Number342584
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 2019-02-08

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