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 2019-03-07 for BN PROSPEC SYSTEM 10465217 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[141644186] The customer contacted a siemens customer care center and reported that an elevated free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system. The customer previously contacted siemens regarding elevated flc lambda results obtained for this patient and mdrs 9610806-2019-00006, 9610806-2019-00007, 9610806-2019-00008, and 9610806-2019-00009 were filed for the elevated flc lambda results previously obtained on the other samples from this patient. Siemens previously determined that the cause of the elevated flc lambda results was sample specific. On 14-jan-2019, the customer sent a sample from the patient for further investigation; siemens further investigated the issue and a study was performed on the affected sample. The sample was tested on a bn prospec system using the same reagent, and the flc lambda result confirmed the elevated recovery observed by the customer. Analysis of the sample portrayed that the flc lambda determinations were correctly evaluated by the bn prospec system; flc lambda concentration was present in a large protein complex in the sample. The system is performing according to specifications. No further evaluation of this device is required. Mdrs 9610806-2019-00006_s3, 9610806-2019-00007_s3, 9610806-2019-00008_s1, and 9610806-2019-00009_s1, 9610806-2019-00012, 9610806-2019-00013, and 9610806-2019-00014 were filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10


[141644187] An elevated free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system. It is unknown if the elevated result was reported to the physician(s) and it is unknown if the sample was repeated. The customer reported that when samples from this patient were tested using a non-siemens methodology, the flc lambda results recovered within normal ranges. There are no known reports of patient intervention or adverse health consequences due to the elevated flc lambda result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2019-00011
MDR Report Key8399214
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-03-07
Date of Report2019-07-17
Date of Event2019-01-07
Date Mfgr Received2019-06-21
Date Added to Maude2019-03-07
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 G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer StreetEMIL-VON-BEHRING-STR. 76 REGISTRATION NUMBER:3003601075
Manufacturer CityMARBURG, D-35041
Manufacturer CountryGM
Manufacturer Postal CodeD-35041
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBN PROSPEC SYSTEM
Generic NameBN PROSPEC SYSTEM
Product CodeJZW
Date Received2019-03-07
Model NumberBN PROSPEC SYSTEM
Catalog Number10465217
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 2019-03-07

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