BCS XP SYSTEM 10459330

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 2019-03-19 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[139237738] The customer contacted a siemens customer care center (ccc). The customer reported that they calculated the affected patients' prothrombin time (pt) international normalized ratio (inr) results with the international sensitivity index (isi) value in the table of assigned values (tav); this is acceptable when the pt inr calculation is intended to be performed on the bcs xp system. However, the customer calculated the pt inr results on a non-siemens laboratory information system (lis); as per a siemens communication to customers in december of 2012, when customers rollover to a dade innovin reagent lot, customers are instructed to contact the siemens technical solutions center to obtain the correct isi to be updated in the lis. The customer indicated that they are aware of this communication, contacted siemens, and siemens provided a letter to the customer (dated 15-jan-2019) with the correct isi value to use for their dade innovin reagent lot (549722). As per siemens instructions, the customer updated the isi result in their lis. Siemens further investigated the issue and determined that there was no instrument or reagent malfunction; the bcs xp system evaluated the results correctly and the results were correctly transmitted to the lis. A use error contributed to the incorrect pt inr results. The system is performing according to specifications. No further evaluation of this device is required. Mdrs 9610806-2019-00015_s1, 9610806-2019-00016, 9610806-2019-00017, 9610806-2019-00018, 9610806-2019-00019, 9610806-2019-00021, 9610806-2019-00022, 9610806-2019-00023, 9610806-2019-00024, 9610806-2019-00025, 9610806-2019-00026, 9610806-2019-00027, 9610806-2019-00028, 9610806-2019-00029, 9610806-2019-00030, 9610806-2019-00031, 9610806-2019-00032, 9610806-2019-00033, 9610806-2019-00034, 9610806-2019-00035, and 9610806-2019-00036 were filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10


[139237739] The customer reported that they've used the incorrect international sensitivity index (isi) value in a non-siemens laboratory information system (lis) to calculate international normalized ratio (inr) results after the samples were processed correctly on a bcs xp system. The customer used the isi value of 0. 93 to calculate patient samples' inr results instead of the isi value of 1. 09. The customer indicated that since (b)(6) 2019, they reported patients' inr results using the incorrect isi value daily for 3 weeks. As per the customer, 26 patients (41 samples) were impacted by this issue. The customer did not identify which patients were impacted nor the dates of testing. The patient's inr results were recalculated using the correct isi value. The correct inr results were reported to the physician(s). There was no report of patient intervention or adverse health consequences due to the customer using the incorrect international sensitivity index (isi) value to calculate inr results for patient samples.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2019-00020
MDR Report Key8433111
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-03-19
Date of Report2019-03-19
Date of Event2019-01-21
Date Mfgr Received2019-02-20
Date Added to Maude2019-03-19
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 ContactMR. BENLEY SAINT-JEAN
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242398
Manufacturer G1BIT ANALYTICAL INSTRUMENTS GMBH
Manufacturer StreetREGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3
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 Received2019-03-19
Model NumberBCS XP SYSTEM
Catalog Number10459330
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 2019-03-19

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