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.
[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
| Report Number | 2250051-2000-00062 |
| MDR Report Key | 279680 |
| Report Source | 05 |
| Date Received | 2000-05-24 |
| Date of Report | 2000-05-03 |
| Date of Event | 2000-05-03 |
| Date Facility Aware | 2000-05-03 |
| Report Date | 2000-05-22 |
| Date Reported to Mfgr | 2000-05-22 |
| Date Added to Maude | 2000-06-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CINDY ADEN |
| Manufacturer Street | 1001 US HWY 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9082188761 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO ELISA BAR CODE READER II |
| Generic Name | BAR CODE READER |
| Product Code | LRH |
| Date Received | 2000-05-24 |
| Model Number | 9720C01,D01,E01,F01 |
| Catalog Number | 935240 |
| Lot Number | NA |
| ID Number | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 269764 |
| Manufacturer | INTERMEC CORP./GREENBROOK CORPORATE CENTER |
| Manufacturer Address | 100 PASSAIC AVE FAIRFIELD NJ 07004 US |
| Baseline Brand Name | ORTHO ELISA BAR CODE READER II |
| Baseline Generic Name | BAR CODE READER |
| Baseline Model No | 9720C01,D01,E01 |
| Baseline Catalog No | 935240 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-05-24 |