MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-07-28 for PLATELET PGD TEST SYSTEM P100T manufactured by Verax Biomedical Inc.
[21642121]
A user facility reported three occasions of a pgd positive control that did not give the expected results. The reported events occurred on (b)(6) 2010. The problem manifests itself as non-reactive platelet pdg test results on the gram-negative side of the test device when testing known gram-negative samples. All three reports occurred during testing of the device prior to use. There was no pt involvement related to these events.
Patient Sequence No: 1, Text Type: D, B5
[21825995]
A device evaluation was performed and it was found that the product was manufactured with both sides of device containing a gram-positive conjugate band, in place of one side having gram-positive and the other gram-negative. Root cause has been determined to be an operator error. It was found that an operator placed gram-positive conjugate band on the gram-negative side of the testing device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004548776-2010-00006 |
| MDR Report Key | 1779625 |
| Report Source | 05,06 |
| Date Received | 2010-07-28 |
| Date of Report | 2010-07-20 |
| Date of Event | 2010-07-04 |
| Date Mfgr Received | 2010-07-20 |
| Device Manufacturer Date | 2010-03-10 |
| Date Added to Maude | 2011-02-14 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN MILLER, VP |
| Manufacturer Street | THREE CORPORATE DRIVE |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer G1 | VERAX BIOMEDICAL INC |
| Manufacturer Street | 377 PLANTATION STREET 4 BIOTECH |
| Manufacturer City | WORCESTER MA 01605 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01605 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3004548776-7/21/10-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLATELET PGD TEST SYSTEM |
| Product Code | MZC |
| Date Received | 2010-07-28 |
| Returned To Mfg | 2010-07-16 |
| Model Number | P100T |
| Catalog Number | P100T |
| Lot Number | L06184 |
| ID Number | 09435-001 |
| Device Expiration Date | 2011-01-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERAX BIOMEDICAL INC |
| Manufacturer Address | WORCESTER MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-28 |