PRISM HTLV-I/HTLV-II 6E50-68

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-04-07 for PRISM HTLV-I/HTLV-II 6E50-68 manufactured by Abbott Laboratories.

Event Text Entries

[828036] The customer generated discrepant results between abbott prism htlv-i/htlv-ii, abbott htlv-i/ii eia, ortho eia, and inno-lia (innogenetics lia is not a licensed test and is used for research purposes only) on five samples. The exact number of freeze thaw cycles for the samples is unk. The following info is for donor sample four of five. Sample 5598527 tested prism htlv negative, htlv eia repeat reactive, and lia positive. The sample was sent to another laboratory where it tested ortho eia repeat reactive and lia positive. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5


[7989791] The prism htlv-i/htlv-ii list 6e50 package insert states in the specimen collection and preparation for analysis section that some specimens that have undergone multiple freeze-thaw cycles or have been stored frozen for prolonged periods may give erroneous or inconsistent test results. The sample for which the discrepant test results was observed had been stored since 2006 and the number of freeze/thaw cycles is unk. H6: this is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1415939-2008-00051
MDR Report Key1026156
Report Source00
Date Received2008-04-07
Date of Report2008-03-10
Date of Event2008-03-10
Date Mfgr Received2008-03-10
Device Manufacturer Date2008-01-01
Date Added to Maude2008-09-05
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 ContactSUDARSHAN HEBBAR, MD
Manufacturer Street100 ABBOTT PARK RD.
Manufacturer CityABBOTT PARK IL 600646112
Manufacturer CountryUS
Manufacturer Postal600646112
Manufacturer Phone8479379677
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRISM HTLV-I/HTLV-II
Generic NameCHLIA FOR THE QUALITATIVE DETECTION OF ANTI-HTLV-I/HTLV-II
Product CodeLRM
Date Received2008-04-07
Model NumberNA
Catalog Number6E50-68
Lot Number54798M101
ID NumberNA
Device Expiration Date2008-05-04
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1023393
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-04-07

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