HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-68

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2007-12-28 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-68 manufactured by Abbott Laboratories.

Event Text Entries

[749643] The customer stated, they had twelve samples that were reactive on initial and repeat testing for (rdna) eia on the quantum ii with lot #55425m100 and lot # 55896m100. The samples were all low level reactive, just above the cutoff. The samples were sent out for confirmatory testing and came back western block negative. The customer stated that quantum maintenance is up to date. They have cultured their water source with no growth indicated and the tubing is clear and not damaged. No medical history was available for the pt samples. A follow-up with the customer in late 2007 revealed that the customer had received several more low level reactive results. Repeat testing on a different lot was negative. The customer provided data for six of the twelve pts. This data is for pt two of six. No impact to pt mgmt was reported.
Patient Sequence No: 1, Text Type: D, B5


[8090326] 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 Number1415939-2007-00275
MDR Report Key970832
Report Source04,05
Date Received2007-12-28
Date of Report2007-11-29
Date of Event2007-10-04
Date Mfgr Received2007-11-29
Device Manufacturer Date2007-07-01
Date Added to Maude2008-03-18
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 ContactDR. DAVID BARCH, D-09Y6, AP6C-2
Manufacturer Street100 ABBOTT PARK RD.
Manufacturer CityABBOTT PARK IL 600646092
Manufacturer CountryUS
Manufacturer Postal600646092
Manufacturer Phone8479379328
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHIVAB HIV-1/HIV-2 (RDNA) EIA
Generic NameEIA FOR DETECTION OF AB TO HIV I AND II
Product CodeLRM
Date Received2007-12-28
Model NumberNA
Catalog Number3A77-68
Lot Number55425M100
ID NumberNA
Device Expiration Date2007-12-02
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key973543
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-12-28

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