MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-11-24 for ABBOTT COMMANDER FPC 3A46-01 manufactured by Abbott Manufacturing, Inc..
[18834081]
On or around 10/14/1999, the account obtained a false negative hepatitis c virus result for a pt sample, which was tested with the fpc. The fpc had dropped tips in three sample tube wells (c5, f4, f5) and the fpc continued pipetting with no error code generated. Diluent was dispensed into the wells and the fpc map showed the wells as filled, not void the account stated that the three samples were not pipetted and repeated those samples at end of the run (wells h1, h2, h3). On the "ppc" data printout, wells c5, f4, and f5 were nonreactive. Retest results for the same samples at the end of the run were:h1-nonreactive, h2-reactive, h3-nonreactive. Pt sample was in wells f4 (nonreactive) and h2 (reactive). The initial results were not reported. No confirmation testing was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-1999-00061 |
| MDR Report Key | 251992 |
| Report Source | 06 |
| Date Received | 1999-11-24 |
| Date of Report | 1999-11-19 |
| Date of Event | 1999-10-14 |
| Date Mfgr Received | 1999-10-22 |
| Device Manufacturer Date | 1996-02-01 |
| Date Added to Maude | 1999-12-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL LANDESMAN |
| Manufacturer Street | 200 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643500 |
| Manufacturer Phone | 8479372688 |
| 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 | 1999-11-24 |
| Returned To Mfg | 1999-11-16 |
| Model Number | NA |
| Catalog Number | 3A46-01 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 244050 |
| 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 | 3A46-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-24 |