BN PROSPEC SYSTEM 10465217

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 2018-04-04 for BN PROSPEC SYSTEM 10465217 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[104702749] The customer reported that the patient was monitored for kappa and lambda for some time using electrophoresis and the alternate non-siemens method. The customer recently started using siemens n latex flc lambda and n latex flc kappa reagents for determination of flc lambda and flc kappa. A siemens headquarters support center (hsc) specialist reviewed the data files on the bn prospec system when the customer previously reported discordant flc lambda and flc kappa results and found no issue. The hsc specialist determined that the save data files contained two quality control (qc) measurements and these results were within expected ranges. The hsc specialist also reviewed the qc kinetics and did not identify any issue. The hsc specialist concluded that there was no indication of a reagent or system malfunction. The cause of the event is unknown. The system and reagents are performing according to specifications. No further evaluation of these devices is required. Mdr 9610806-2018-00035, mdr 9610806-2018-00036, and mdr 9610806-2018-00037 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10


[104702750] Different free light chains (flc), type lambda (flc lambda) and flc, type kappa (flc kappa) results were obtained on a patient sample on the bn prospec system using the siemens' n latex flc lambda and n latex flc kappa reagents compared to an alternate non-siemens reagent. The patient started chemotherapy for myeloma in (b)(6) 2018 and it is unknown whether any of these results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the different flc kappa and flc lambda results obtained on the patient sample.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2018-00038
MDR Report Key7397582
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-04-04
Date of Report2018-04-30
Date of Event2018-03-21
Date Mfgr Received2018-04-05
Date Added to Maude2018-04-04
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 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 NameBN PROSPEC SYSTEM
Generic NameBN PROSPEC SYSTEM
Product CodeJZW
Date Received2018-04-04
Model NumberBN PROSPEC SYSTEM
Catalog Number10465217
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 2018-04-04

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