MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2000-10-12 for ULTEGRA RPFA-TRAP 85013 INSTR manufactured by Accumetrics.
[201134]
As part of a clinical trial involving platelet function measurements with the ultegra rpfa, a blood sample was drawn from a study subject. Prior to administration of any platelet inhibitor drugs, an rpfa-trap result of 6 pau was obtained. This value is suspect because it is significantly lower than the baseline reference range cited in the device package insert (125-330 pau). The test was repeated, and the result was 308 pau. The analyzer and cartridges were labeled "investigational use only", and no decisions regarding pt care were made based on these results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031760-2000-00011 |
| MDR Report Key | 300774 |
| Report Source | 02,05 |
| Date Received | 2000-10-12 |
| Date of Report | 2000-10-12 |
| Date of Event | 2000-09-12 |
| Date Mfgr Received | 2000-09-12 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 2000-10-20 |
| 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 | BARBARA STEVENS |
| Manufacturer Street | 3985 SORRENTO VALLEY BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586431600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTEGRA RPFA-TRAP |
| Generic Name | PLATELET FUNCTION ASSAY |
| Product Code | JOZ |
| Date Received | 2000-10-12 |
| Model Number | NA |
| Catalog Number | 85013 INSTR |
| Lot Number | W11584 |
| ID Number | 85011 CARTRIDGE |
| Device Expiration Date | 2000-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 291126 |
| Manufacturer | ACCUMETRICS |
| Manufacturer Address | 3985 B SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US |
| Baseline Brand Name | ULTEGRA RPFA-TRAP |
| Baseline Generic Name | PLATELET FUNCTION ASSAY |
| Baseline Catalog No | 85013 INSTR |
| Baseline ID | 85011 CARTRIDGE |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 6 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K992531 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-10-12 |