BN PROSPEC? SYSTEM 10444804

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-29 for BN PROSPEC? SYSTEM 10444804 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[59030771] The cause of the discrepant flc results is an instrument malfunction of the diluent pump. The customer runs igg subclasses with a siemens reagent and measures free light chain (flc) kappa and lambda with the non-siemens binding site reagent on the bn prospec. The siemens igg subclasses reagents were showing qc results out of laboratory ranges but some of the flc qc was within laboratory limits. No instrument errors were logged. The customer went ahead and ran all flc patients and released the results to the doctor while the analyser was failing the diluent pump calibration. As no error was displayed, the operator continued running the analyser reporting out incorrect results for the binding site flc kappa and lambda. A field engineer replaced the diluent pump and returned the instrument to service. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


[59030772] Discrepant free light chain (flc) results (kappa and lambda) were obtained on patient samples with the binding site flc reagent on the bn prospec instrument. The results were reported to the physician who questioned the results. After an instrument malfunction was identified and repaired, the same samples were repeated and corrected results were issued. There is no indication that patient treatment was altered or prescribed on the basis of the discrepant flc kappa and lambda results. There was no report of adverse health consequences as a result of the discrepant flc kappa and lambda results.
Patient Sequence No: 1, Text Type: D, B5


[61656017] Initial mdr (2517506-2016-00396) was filed on 10/29/2016. Corrected information (10/31/2016): sections manufacturer name, city and state and manufacturing site address/phone for devices were updated with the correct manufacturer name and address. A corrected mdr was submitted under the appropriate manufacturer report number. The correct manufacturer report number should have been 9610806-2016-00036.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2517506-2016-00396
MDR Report Key6065631
Date Received2016-10-29
Date of Report2016-11-21
Date of Event2016-09-26
Date Mfgr Received2016-10-31
Device Manufacturer Date2005-05-01
Date Added to Maude2016-10-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAMES MORGERA
Manufacturer StreetGLASGOW BUSINESS COMMUNITY PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer StreetEMIL VON BEHRING STRASSE 76 101 SILVERMINE ROAD
Manufacturer CityMARBURG, CT 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 Received2016-10-29
Model NumberBN PROSPEC
Catalog Number10444804
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer AddressEMIL VON BEHRING STRASSE 76 500 GBC DRIVE MARBURG, DE D-35041 GM D-35041


Patients

Patient NumberTreatmentOutcomeDate
10 2016-10-29

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