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 from a 05 report with the FDA on 2000-05-24 for ORTHO ELISA BAR CODE READER II 9720C01,D01,E01,F01 935240 manufactured by Intermec Corp./greenbrook Corporate Center.

Event Text Entries

[17439345] The customer reported while using a hand held intermec barcode wand, it read a sample barcode incorrectly as "184613865" instead of "018gk13865". No death or serious injury was associated with this event. This report corresponds to ortho-clinical diagnostics complaint number 00-02186-05.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2250051-2000-00062
MDR Report Key279680
Report Source05
Date Received2000-05-24
Date of Report2000-05-03
Date of Event2000-05-03
Date Facility Aware2000-05-03
Report Date2000-05-22
Date Reported to Mfgr2000-05-22
Date Added to Maude2000-06-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCINDY ADEN
Manufacturer Street1001 US HWY 202
Manufacturer CityRARITAN NJ 08869
Manufacturer CountryUS
Manufacturer Postal08869
Manufacturer Phone9082188761
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameORTHO ELISA BAR CODE READER II
Generic NameBAR CODE READER
Product CodeLRH
Date Received2000-05-24
Model Number9720C01,D01,E01,F01
Catalog Number935240
Lot NumberNA
ID NumberNA
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key269764
ManufacturerINTERMEC CORP./GREENBROOK CORPORATE CENTER
Manufacturer Address100 PASSAIC AVE FAIRFIELD NJ 07004 US
Baseline Brand NameORTHO ELISA BAR CODE READER II
Baseline Generic NameBAR CODE READER
Baseline Model No9720C01,D01,E01
Baseline Catalog No935240
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2000-05-24

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