MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for VERAX PLATELET PGD TEST manufactured by Verax Biomedical Incorporated.
[124101705]
Verax platelet pan genara detection (pgd) testing is performed on non-pathogen reduced platelets for the detection of bacteria. The test is manufactured by verax biomedical and is fda approved for the rapid -detection of bacterial contamination of platelet products. Platelet products that have not been pathogen reduced and are still in inventory on days 4 and 5 after collection are tested for bacterial contamination using the verax pgd test kit. Last week, two stem cell transplant patients received bacterially contaminated platelet. The platelet products were tested for bacterial contamination (verax pgd) on day 4 and the results were (b)(6). Patient was transfused at the same location. The testing was performed and cultures reports (b)(6) for acinetobacter baumannii.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7977033 |
| MDR Report Key | 7977033 |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-10-04 |
| Report Date | 2018-10-11 |
| Date Reported to FDA | 2018-10-11 |
| Date Reported to Mfgr | 2018-10-18 |
| Date Added to Maude | 2018-10-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERAX PLATELET PGD TEST |
| Generic Name | SYSTEM, DETECTION, BACTERIAL, FOR PLATELET TRANSFUSION PRODUCTS |
| Product Code | MZC |
| Date Received | 2018-10-18 |
| Lot Number | REAGENT1-L10026, L10028, L1003 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERAX BIOMEDICAL INCORPORATED |
| Manufacturer Address | 148 BARTLETT ST MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-18 |