MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-12-02 for ABBOTT COMMANDER FPC 3A46-47 manufactured by Abbott Manufacturing, Inc..
[345026]
The account stated the flexible pipetting center internal barcode and external barcode reader were misreading patient barcode labels intermittently. The account stated the characters were read incorrectly, for example the number 4 was read as the number 9. The account stated the barcode labels did not appear to be damaged or too dark. The misread specimen labels were noticed and no results were reported outside of the laboratory. Service was requested for the flexible pipetting center. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2004-00042 |
| MDR Report Key | 580000 |
| Report Source | 06 |
| Date Received | 2004-12-02 |
| Date of Report | 2004-11-30 |
| Date of Event | 2004-11-08 |
| Date Mfgr Received | 2004-11-08 |
| Date Added to Maude | 2005-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID SPINDELL, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT COMMANDER FPC |
| Generic Name | AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS |
| Product Code | LQI |
| Date Received | 2004-12-02 |
| Model Number | NA |
| Catalog Number | 3A46-47 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 569848 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Baseline Brand Name | ABBOTT COMMANDER FPC |
| Baseline Generic Name | AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS |
| Baseline Model No | NA |
| Baseline Catalog No | 3A46-47 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-02 |