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

[104560631] The customer reported that the patient was monitored for kappa and lambda for some time using electrophoresis and the alternate non-siemens method; this was unknown by the customer when they reported the flc kappa and flc lambda results using siemens n latex flc lambda and n latex flc kappa reagents. The customer also indicated that they recently started using siemens reagents for determination of flc lambda and flc kappa and that the affected specimen is not available for further investigation. A siemens headquarters support center (hsc) specialist reviewed the data files on the bn prospec system to determine the cause of the event 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 kinetics of the affected measurement on 21-feb-2018 and qc and did not identify any issue. The kinetics of the sample measurement using the non-siemens method, which is not validated for use on the bn prospec system, were not in the data files provided by the customer. 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 9610806-2018-00036, mdr 9610806-2018-00037, and mdr 9610806-2018-00038 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10


[104560632] Discordant, falsely low free light chains (flc), type lambda (flc lambda) results were obtained on a patient sample on the bn prospec system using the n latex flc lambda reagent. These results were reported to the physician(s), who questioned the results as they did not match the patient's clinical history. The sample was also rerun on the same system using a higher dilution (to exclude a dose hook effect) and a result of <9. 94 mg/l was obtained. The sample was rerun on the same system, using a non-siemens method, resulting higher. The 3rd repeat result was reported as the expected result to the physician(s). Additionally, different free light chains (flc), type kappa (flc kappa) results were obtained on the same sample between the non-siemens method and the n latex flc kappa reagent on the same system. The 2nd repeat flc kappa result was run to exclude a high dose hook effect. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc lambda results and different flc kappa results obtained on the patient sample.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2018-00035
MDR Report Key7397584
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-04-04
Date of Report2018-04-30
Date of Event2018-02-20
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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