MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2000-08-04 for ULTEGRA RPFA-TRAP 85013 INSTR. manufactured by Accumetrics.
[180824]
A blood sample was drawn from a pt to obtain a baseline (pre-drug) platelet function test result using the ultegra rpfa-trap. A result of 56 "pau" was obtained. This value is significantly lower than the baseline reference range cited in the device package insert (125-330 "pau"). A second blood sample was drawn, and the retest gave a result of 141 "pau".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031760-2000-00009 |
| MDR Report Key | 288947 |
| Report Source | 06,07 |
| Date Received | 2000-08-04 |
| Date of Report | 2000-08-04 |
| Date of Event | 2000-07-06 |
| Date Mfgr Received | 2000-07-07 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2000-08-10 |
| 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 | 2000-08-04 |
| Model Number | NA |
| Catalog Number | 85013 INSTR. |
| Lot Number | W03876, W11247 |
| ID Number | 85011 CARTRIDGE |
| Device Expiration Date | 2000-09-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 279623 |
| Manufacturer | ACCUMETRICS |
| Manufacturer Address | 3985 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 | 2000-08-04 |