IMMULITE 2000 IGF-1 L2KGF

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 2012-12-10 for IMMULITE 2000 IGF-1 L2KGF manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[18526286] The customer states that they have observed positive bias with the insulin-like growth factor (igf-1) assay on kit lots 486 and 487. There were no reports of patient intervention or adverse health consequences due to the discordant igf-1 results.
Patient Sequence No: 1, Text Type: D, B5


[18754078] The cause of the increase in abnormal results for igf-1 is unknown. An urgent field safety notice (ufsn), ufsn 4005 - "immulite / immulite 1000 / immulite 2000 / immulite 2000 xpi all immulite platforms for igf-i shift in patient medians and supply disruption" was sent to customers in november 2012. Siemens is investigating this issue. New date of awareness: during a lookback of pmdrs related to the igf-1 bias field correction, this complaint was identifiedas belonging to the issue addressed in the field correction. On 11/09/2012, the decision to issue a ufsn (ufsn 4005) was made due to a positive shift in patient medians of approximately 20% which occurred between late 2009 and mid 2011. The performance of the kit lots currently in distribution is in alignment with the reference range data published in the instructions for use (ifu).
Patient Sequence No: 1, Text Type: N, H10


[19059509] The initial mdr 2432235-2012-00424 was filed on (b)(4) 2012. (b)(4) 2012: additional information: the corrections and removal report (crr) was filed with the fda on (b)(6) 2012. The crr number is 2432235-11/28/2012-007-c.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2432235-2012-00424
MDR Report Key2864186
Report Source05,06
Date Received2012-12-10
Date of Report2012-11-09
Date of Event2012-09-13
Date Mfgr Received2012-11-28
Date Added to Maude2013-03-14
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 FDA0
Event Location0
Manufacturer ContactMINDY LOSAPIO
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242312
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer StreetGLYN RHONWY LLANBERIS, CAERNARFON
Manufacturer CityGWYNEDD, WALES LL554EL
Manufacturer CountryUK
Manufacturer Postal CodeLL55 4EL
Single Use3
Previous Use Code3
Removal Correction Number2432235-11/28/2012-007-C
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000 IGF-1
Generic NameIMMULITE 2000
Product CodeCFL
Date Received2012-12-10
Model NumberIMMULITE 2000 IGF-1
Catalog NumberL2KGF
Lot Number486; 487
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer AddressGLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-10

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