IMMULITE 2000 30002

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 2015-06-09 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[5843334] Discordant, falsely elevated 3gallergy specific ige results were obtained on multiple patient samples on an immulite 2000 instrument. The discordant results were not reported to the physician(s). After troubleshooting, the samples were repeated on the same instrument, resulting lower. The repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant 3gallergy specific ige results.
Patient Sequence No: 1, Text Type: D, B5


[13294323] A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse replaced dirty inline filters and cleaned the water bottle. The cse made new probe wash and performed a system decontamination. The cse ran a water test and quality controls, which were within acceptable ranges. The cause of the discordant, falsely elevated 3gallergy specific ige results on multiple patient samples is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2247117-2015-00034
MDR Report Key4828356
Report Source05,06
Date Received2015-06-09
Date of Report2015-05-15
Date of Event2015-05-15
Date Mfgr Received2015-05-15
Date Added to Maude2015-07-07
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 FDA0
Event Location0
Manufacturer ContactMICHAEL METZ
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242223
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Street62 FLANDERS BARTLEY ROAD
Manufacturer CityFLANDERS NJ 07836
Manufacturer CountryUS
Manufacturer Postal Code07836
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000
Generic NameIMMULITE 2000
Product CodeDHB
Date Received2015-06-09
Model NumberIMMULITE 2000
Catalog Number30002
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-09

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