FACTOR VIII CHROMOGENIC ASSAY 10445729

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-22 for FACTOR VIII CHROMOGENIC ASSAY 10445729 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[93433487] Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, high factor viii patient result on the bcs xp system. No product non-conformance could be identified and all information that was provided indicates a possible sample specific issue. The instrument and reagent are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10


[93433488] A discordant, high factor viii patient result (chromogenic factor viii assay) was generated on the bcs xp system compared to a chromogenic factor viii assay patient result generated at another reference lab (esoterix). A different patient sample (from the same patient) was used at esoterix, but it is not known what system was used. Factor viii activity was also high on that patient sample on the bcs xp system compared to the factor viii activity result generated at the reference lab (esoterix). Quality controls were in range. There are no reports of patient intervention or adverse health consequence due to the discordant, high factor viii patient result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2017-00134
MDR Report Key7053625
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-11-22
Date of Report2017-11-22
Date of Event2017-10-12
Date Mfgr Received2017-10-27
Device Manufacturer Date2016-03-24
Date Added to Maude2017-11-22
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 ContactLORIANN RUSSO
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242287
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer StreetEMIL VON BEHRING STRASSE 76
Manufacturer CityMARBURG, 35041
Manufacturer CountryGM
Manufacturer Postal Code35041
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFACTOR VIII CHROMOGENIC ASSAY
Generic NameFACTOR VIII CHROMOGENIC ASSAY
Product CodeGGP
Date Received2017-11-22
Catalog Number10445729
Lot Number529391
Device Expiration Date2018-02-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer AddressEMIL VON BEHRING STRASSE 76 MARBURG, 35041 GM 35041


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-22

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