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 2001-05-08 for ORTHO ELISA BAR CODE READER II 9720C01, D01, E01, F01 935240 manufactured by Intermec Corp.

Event Text Entries

[21694960] The customer reported while running a hepatitis surface antigen assay, using a hand held intermec barcode wand read a sample barcode incorrectly. Software support determined the probable cause of the barcode misread was due to the barcode wand. No death or serious injury was associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2250051-2001-00455
MDR Report Key332741
Date Received2001-05-08
Date of Report2001-04-25
Date of Event2001-04-25
Date Facility Aware2001-04-25
Report Date2001-04-25
Date Reported to Mfgr2001-05-08
Date Added to Maude2001-05-17
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 Received2001-05-08
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 Key322109
ManufacturerINTERMEC CORP
Manufacturer Address100 PASSAIC AVE GREENBROOK CORP CENTER 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 2001-05-08

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