IMMULITE 2000 3GALLERGY SPECIFIC IGE L2KUN6

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 2018-05-22 for IMMULITE 2000 3GALLERGY SPECIFIC IGE L2KUN6 manufactured by Siemens Healthcare Diagnostics Products, Limited.

Event Text Entries

[108994226] A siemens headquarters support center (hsc) specialist reviewed the kit release data for the latest lot (kit lot 602) available for immulite 2000 3gallergy specific ige results for rat allergen (e87), which showed that the allergen is performing as expected. The hsc specialist concluded that the potential cause of the discordant results could be due to the sample specific issue. The device is performing as expected. No further evaluation of device is required. Mdr 2432235-2018-00207 has been filed for the same event for allergen e73 which has different 510(k) # of k013134.
Patient Sequence No: 1, Text Type: N, H10


[108994227] Discordant, false negative 3gallergy specific ige result for rat allergen (e87) (510 (k) # k021206) was obtained on one patient sample on an immulite 2000 xpi instrument, while using an unknown kit lot. The sample was also tested negative for rat epithelium allergen (e73) (510 (k) # k013134). The sample was repeated on an alternate platform for allergens e87 and e73, resulting positive. It is unknown which results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant 3gallergy specific ige results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2432235-2018-00206
MDR Report Key7533657
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-05-22
Date of Report2018-07-20
Date of Event2018-04-24
Date Mfgr Received2018-06-04
Date Added to Maude2018-05-22
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 ContactSHWETA GULATI
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242870
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer StreetUK REGISTRATION #: 3002806944 GLYN RHONWY
Manufacturer CityLLANBERIS, GWYNEDD LL554EL
Manufacturer CountryUK
Manufacturer Postal CodeLL55 4EL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000 3GALLERGY SPECIFIC IGE
Generic NameIMMULITE 2000 3GALLERGY SPECIFIC IGE
Product CodeDHB
Date Received2018-05-22
Model NumberIMMULITE 2000 3GALLERGY SPECIFIC IGE
Catalog NumberL2KUN6
Lot Number209
Device Expiration Date2018-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer AddressGLYN RHONWY LLANBERIS GWYNEDD, LL554EL UK LL55 4EL


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-22

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