BCS XP SYSTEM 11240019

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 2018-08-21 for BCS XP SYSTEM 11240019 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[118116712] The customer contacted a siemens customer care center and reported that discordant results were obtained on an icteric sample on the bcs xp systems. Siemens reviewed the system files for the bcs xp system with serial number (sn) (b)(4) and determined that the bcs xp system with sn (b)(4) performed as intended; siemens determined that the sample had an absorbance that exceeded the photometer capability on the bcs xp system. The patient sample also contained a bilirubin value of >30 mg/dl, which exceeded the bilirubin interference limitation 12 mg/dl listed in the bcs xp system reference guide for multifibren u; the other coagulation test results also indicated that the sample was highly turbid. The cause of the discordant, falsely elevated fibrinogen results and imprecise pt % and pt inr results was potentially due to a sample specific issue. The systems are performing according to specifications. No further evaluation of these devices is required. Mdr 9610806-2018-00082 was filed for the discordant results obtained on the bcs xp system with sn (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[118116713] The customer reported that a flagged fibrinogen result was obtained on a patient sample on the bcs xp system with serial number (sn) (b)(4) and was not transferred to the host. Due to this, the sample was repeated on the same system, resulting in a discordant, falsely elevated fibrinogen result. The discordant result was not reported to the physician(s). The same sample was repeated using the fibrinogen 570 and fibrinogen low 570 assays, resulting in a non-numerical result and an expected result for the patient. The sample was repeated for fibrinogen, fibrinogen 570 and fibrinogen low 570 on the bcs xp system with sn (b)(4), resulting in an elevated result, a non-numerical result and an expected result. The customer stated that the expected range for fibrinogen for this patient was between 50 and 100 mg/dl and did not indicate which results were reported to the physician(s). Additionally, imprecise prothrombin time (pt) % and pt international normalized ratio (inr) results were also obtained on the patient sample on the bcs xp system with sn (b)(4). The sample was also repeated on the bcs xp system with sn (b)(4) for pt % and pt inr, resulting lower for pt % and higher for pt inr than most pt results obtained on the bcs xp system with sn (b)(4). It is unknown whether any of the pt % or pt inr results was reported to the physician(s) and the correct results are unknown. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated fibrinogen result and imprecise pt % and pt results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2018-00083
MDR Report Key7802840
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-08-21
Date of Report2018-08-21
Date of Event2018-07-25
Date Mfgr Received2018-07-27
Date Added to Maude2018-08-21
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 Received2018-08-21
Model NumberBCS XP SYSTEM
Catalog Number11240019
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2018-08-21

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