MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-10 for ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER #2 * manufactured by Abbott Laboratories.
[163255]
Hepatitis b surface antigen testing. Initial installation of software was set up with different parameters intended to be the same. Different software parameters resulted in different cut off limits. Approx 97 pts were reported as negative but could have fallen in an indeterminate range. Indeterminate findings are routinely repeated and most often found to be negative. Staff researching how many were re-tested because of continued symptoms. Physician notification undertaken and repeat testing will be offered. Different software parameters were present previously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018124 |
| MDR Report Key | 262251 |
| Date Received | 2000-02-10 |
| Date of Report | 2000-02-09 |
| Date of Event | 1998-10-01 |
| Date Added to Maude | 2000-02-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER #2 |
| Generic Name | SOFTWARE |
| Product Code | IQW |
| Date Received | 2000-02-10 |
| Model Number | FLEXIBLE PIPETTING CENTER #2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 253994 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-02-10 |