IMMULITE 2000 030002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-02 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[16835778] Discordant rubella quantitative igg (rubg) result was obtained on a patient sample, generated on immulite 2000. The sample was repeated. Patient treatment was not altered or prescribed. There was no report of adverse health consequences as a result of the discordant rubella quantitative igg (rubg) result.
Patient Sequence No: 1, Text Type: D, B5


[17057743] A siemens healthcare field service engineer (fse) was sent to the customer site. Analysis of the instrument and instrument data indicate that the cause for the discordant rubella quantitative igg (rubg) result could not be determined. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2247117-2009-00038
MDR Report Key1492436
Report Source05,06
Date Received2009-10-02
Date of Report2009-09-16
Date of Event2009-09-16
Date Mfgr Received2009-09-16
Date Added to Maude2011-03-21
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 FDA0
Event Location0
Manufacturer ContactLINDA BARLETTA
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242299
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Street62 FLANDERS-BARTLEY RD.
Manufacturer CityFLANDERS NJ 07836
Manufacturer CountryUS
Manufacturer Postal Code07836
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000
Generic NameIMMUNO-ASSAY ANALYZER
Product CodeGOM
Date Received2009-10-02
Model NumberNA
Catalog Number030002
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer AddressFLANDERS NJ 07836 US 07836


Patients

Patient NumberTreatmentOutcomeDate
10 2009-10-02

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