BCS XP SYSTEM 10461894

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 2019-01-10 for BCS XP SYSTEM 10461894 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[134192074] The customer contacted a siemens customer care center and reported that discordant, falsely low fibrinogen results were obtained on two samples from the same patient on a bcs xp system using the fib low 570 assay protocol; additionally, the customer provided the imprecise prothrombin time (pt), pt % and pt international normalized ratio (inr) results obtained on the samples. The customer reported that the issue is observed on two bcs xp systems at the laboratory, but did not provide the data to support their report. The fib570 assay protocol is used as a backup for icteric, hemolyzed or lipemic samples that could not be processed with the fib assay protocol. The fib low assay protocol is used for samples with expected fibrinogen concentration below the normal range that cannot be processed with fib assay protocol. Siemens is investigating the issue. Mdr 9610806-2019-00004 was filed for the discordant result(s) obtained on (b)(6) 2018 for sample id (b)(6) and mdr 9610806-2019-00005 was filed for the discordant result(s) obtained on (b)(6) 2018 for sample id (b)(6) from the same patient.
Patient Sequence No: 1, Text Type: N, H10


[134192075] A discordant, falsely low fibrinogen (fib) result was obtained on a patient sample on a bcs xp system, using the fib low570 assay protocol. The discordant result was not reported to the physician(s). The sample was previously tested for fib on the same system using the fib and fib570 assay protocols, and compared to the discordant result, higher results were obtained using the fib and fib570 assay protocols. The result obtained using the fib570 assay protocol was considered to be correct and was reported to the physician(s). Additionally, imprecise prothrombin time (pt), pt %, and pt international normalized ratio (inr) results were obtained on the sample using the dade innovin reagent and same system. The correct pt %, pt and pt inr results for this patient are unknown and it is unknown if any of the pt %, pt and pt inr results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low fibrinogen result and imprecise pt %, pt and pt inr results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2019-00005
MDR Report Key8233528
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-01-10
Date of Report2019-01-31
Date of Event2018-11-11
Date Mfgr Received2019-01-08
Date Added to Maude2019-01-10
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 ContactCHRISTINA LAM
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243504
Manufacturer G1BIT ANALYTICAL INSTRUMENTS GMBH
Manufacturer StreetAM KRONBERGER HANG 3 REGISTRATION NUMBER:3003601075
Manufacturer CitySCHWALBACH, 65824
Manufacturer CountryGM
Manufacturer Postal Code65824
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBCS XP SYSTEM
Generic NameBCS XP SYSTEM
Product CodeGKP
Date Received2019-01-10
Model NumberBCS XP SYSTEM
Catalog Number10461894
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer AddressEMIL-VON-BEHRING-STR. 76 MARBURG, D-35041 GM D-35041


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.