IMMULITE 2000/IMMULITE 2000 XPI 3G ALLERGEN SPECIFIC IGE L2KUN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2017-12-14 for IMMULITE 2000/IMMULITE 2000 XPI 3G ALLERGEN SPECIFIC IGE L2KUN manufactured by Siemens Healthcare Diagnostics Products, Limited.

Event Text Entries

[95617029] Siemens healthcare diagnostics has confirmed that biotin interferes with the 3g allergen assay on immulite 2000/immulite 2000 xpi platform. At biotin concentrations of >5 ng/ml a negative bias that exceeds 10% has been observed on the immulite 2000/immulite 2000 xpi platforms. This issue affects previously manufactured, in-date, and future lots. The immulite platform instructions for use (ifu's) currently do not have biotin listed as a potential interferent. An urgent field safety notice (ufsn) imc 18-02. A. Ous was sent out to ous customers and an urgent medical device recall (umdr) imc18-02. A. Us was sent to us customers on december 13, 2017. The ufsn and umdr informs the customers of biotin interference on all affected immulite assays. Siemens will update all ifu's with the appropriate biotin information.
Patient Sequence No: 1, Text Type: N, H10


[95617030] Siemens technical operations internal investigation has identified that discordant falsely low results were obtained on two investigational samples on an immulite 2000/ immulite 2000 xpi instrument when using the 3g allergen specific ige assay. Five specific allergens were used for the testing - olive specific allergen, cat dander, latex allergen, wheat allergen, and chironomus spp allergen. The two investigational samples were spiked with biotin at multiple concentrations, for each specific allergen and run for investigational purposes on an immulite 2000/immulite 2000 xpi instrument. A greater than one class change (falsely low) in result was observed at biotin concentrations of 250 ng/ml with olive allergen, 100 ng with cat dander allergen, 75 ng/ml with latex allergen, 250 ng/ml with wheat allergen and 75 ng/ml of chironomus spp allergen respectively compared to results of the two samples without biotin. There were no patient samples impacted as this was for investigational purposes only.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2432235-2017-00643
MDR Report Key7118357
Report SourceFOREIGN,STUDY
Date Received2017-12-14
Date of Report2017-12-19
Date of Event2017-11-21
Date Mfgr Received2017-12-18
Date Added to Maude2017-12-14
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 ContactAARTI AZIZ
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242683
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
Manufacturer StreetUK REGISTRATION #: 3002806944 GLYN RHONWY
Manufacturer CityLLANBERIS, GWYNEDD LL554EL
Manufacturer CountryUK
Manufacturer Postal CodeLL55 4EL
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2432235-12/19/2017-004-C
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000/IMMULITE 2000 XPI 3G ALLERGEN SPECIFIC IGE
Generic NameIMMULITE 2000/IMMULITE 2000 XPI 3G ALLERGEN SPECIFIC IGE
Product CodeDHB
Date Received2017-12-14
Model NumberIMMULITE 2000/IMMULITE 2000 XPI 3G ALLERGEN SPECIF
Catalog NumberL2KUN
Lot Number476
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 2017-12-14

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