ACCESS HFSH 33520

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 2011-10-28 for ACCESS HFSH 33520 manufactured by Beckman Coulter, Inc..

Event Text Entries

[19930922] Customer reported erroneous test results for access hypersensitive htsh (thyroid stimulating hormone), access total t4 (thyroxine), access hlh (luteinizing hormone) and access hfsh (follicle stimulating hormone) were obtained for one pt when using the unicel dxi 800 access immunoassay system. The erroneous high test results were reported out of the lab. Repeat analysis was performed with two alternate systems with correct test results obtained. Sample was analyzed at beckman coulter, inc the presence of a heterophile antibody was identified. There is no report of adverse event or serious injury related to this event. It is unk whether there was a change to pt mgmt. This is event 2 of 4 reported by the customer. An mdr was filed for each of the reagents demonstrating this issue.
Patient Sequence No: 1, Text Type: D, B5


[20279191] Sample was analyzed at beckman coulter, inc. The presence of a heterophile antibody was identified. Product labeling states: "for assays employing antibodies, the possibility exists for interference by heterophile antibodies in the pt sample. Pts who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e. G. Hama, that interfere with immunoassays. Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in pt samples. Such interfering antibodies may cause erroneous results. Carefully evaluate the results of pts suspected of having these antibodies. " root cause was determined to be the presence of a heterophile antibody in the pt's sample. This reportable event was identified during a retrospective review of product between jan 1, 2008 to october 23, 2010 of complaints for add'l reportable events. This event 2 of 4 reported by this customer. The related mdrs are: 2122870-2011-04873, 04913, 04914.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2122870-2011-04912
MDR Report Key2320491
Report Source05,06
Date Received2011-10-28
Date of Report2009-12-11
Date of Event2009-11-03
Date Mfgr Received2009-12-11
Date Added to Maude2012-07-10
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 ContactMS NORA ZEROUNIAN
Manufacturer Street250 S. KRAEMER BLVD.
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer G1BECKMAN COULTER, INC.
Manufacturer Street1000 LAKE HAZELTINE DR.
Manufacturer CityCHASKA MN 55318
Manufacturer CountryUS
Manufacturer Postal Code55318
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCESS HFSH
Product CodeCGJ
Date Received2011-10-28
Model NumberNA
Catalog Number33520
Lot Number911588
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address1000 LAKE HAZELTINE DR. CHASKA MN 55318 US 55318


Patients

Patient NumberTreatmentOutcomeDate
10 2011-10-28

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