IMMULITE 2000 ERYTHROPOIETIN

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 2012-09-12 for IMMULITE 2000 ERYTHROPOIETIN manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[15509544] A discordant, falsely elevated erythropoietin (epo) result was obtained on a patient sample on the immulite 2000 instrument with lot # 230. The initial result was not reported to the physician. The laboratory reported that they could not interpret the result. There were no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated epo result.
Patient Sequence No: 1, Text Type: D, B5


[15749486] The customer called the technical solutions center (tsc) about the discordant epo result. The customer stated that the laboratory has run dilutions on other epo samples and other assays there are no problems. Based on this, the tsc specialist determined that the instrument did not require a field service engineer to inspect. The instructions for use (ifu) for the epo assay on the immulite 2000 instrument does indicate that the assay has limitations. The ifu states: "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays. " the cause of the discordant epo result is unknown.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2432235-2012-00310
MDR Report Key2740509
Report Source05,06
Date Received2012-09-12
Date of Report2012-08-17
Date of Event2012-08-06
Date Mfgr Received2012-08-17
Date Added to Maude2012-12-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
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
Event Type3
Type of Report3

Device Details

Brand NameIMMULITE 2000 ERYTHROPOIETIN
Generic NameERYTHROPOIETIN ASSAY
Product CodeGGT
Date Received2012-09-12
Model NumberIMMULITE 2000
Lot Number230
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2012-09-12

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