ELECSYS AFP ASSAY 04481798190

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 2017-10-11 for ELECSYS AFP ASSAY 04481798190 manufactured by Roche Diagnostics.

Event Text Entries

[90311357] This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[90311358] The customer complained of erroneous results for 1 patient sample tested for elecsys afp assay (afp) on a cobas 8000 e 602 module. The initial afp result from the e602 module was 15. 0 ng/ml. This result was reported outside of the laboratory. The sample was sent to an external laboratory and repeated using the ligand binding assay method from wako and the result was 5. 7 ng/ml. The customer does not known which result is correct. There was no allegation that an adverse event occurred. The e602 module serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-02269
MDR Report Key6940687
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-10-11
Date of Report2017-10-24
Date of Event2017-09-25
Date Mfgr Received2017-09-25
Date Added to Maude2017-10-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 NameELECSYS AFP ASSAY
Generic NameKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Product CodeLOJ
Date Received2017-10-11
Model NumberNA
Catalog Number04481798190
Lot NumberASKU
ID NumberNA
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 2017-10-11

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