ORTHO ELISA BAR CODE READER II 9720C01, D01, E01, F01 935240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-09 for ORTHO ELISA BAR CODE READER II 9720C01, D01, E01, F01 935240 manufactured by Intermec Corp.

Event Text Entries

[17513101] The customer reported while using hand held intermec barcode wand read a sample barcode in well position f10 misread. An hiv-1 p24 antibody assay was being run at the time. No death or serious injury was associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2250051-1999-00866
MDR Report Key249742
Date Received1999-11-09
Date of Report1999-10-12
Date of Event1999-10-12
Date Facility Aware1999-10-12
Report Date1999-11-08
Date Reported to Mfgr1999-11-08
Date Added to Maude1999-11-17
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHO ELISA BAR CODE READER II
Generic NameBAR CODE READER
Product CodeLRH
Date Received1999-11-09
Model Number9720C01, D01, E01, F01
Catalog Number935240
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key241950
ManufacturerINTERMEC CORP
Manufacturer AddressGREENBROOK CORPORATE CENTER 100 PASSAIC AVE FAIRFIELD NJ 07004 US
Baseline Brand NameORTHO ELISA BAR CODE READER II
Baseline Generic NameBAR CODE READER
Baseline Model No9720C01, D01, E
Baseline Catalog No935240
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-11-09

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