MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUES manufactured by Qualigen, Inc..
[130665128]
Urologist tested me for my psa, prostate specific antigen using in doctor's office, the fast pack ip system office analyzer for determining my psa value. This in office psa test was performed, one on the separate occasions, 2 different urologists and 2 different fastpack analyzers. In addition, i also obtained psa values using off site labs, using my va and other health insurance. The psa results are in block 5 of this form. During the first round of testing, the fastpack ip psa results were almost double the 2 traditional lab results. During the second round of test results, the fastpack ip results were again very high compared to the traditional lab results for psa. Possible inflated psa values may lead to inappropriate treatments for low risk prostate cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082129 |
| MDR Report Key | 8164653 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-09-20 |
| Date Added to Maude | 2018-12-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUES |
| Generic Name | PROSTATE - SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Product Code | LTJ |
| Date Received | 2018-12-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUALIGEN, INC. |
| Brand Name | FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUES |
| Generic Name | PROSTATE - SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Product Code | LTJ |
| Date Received | 2018-12-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | QUALIGEN, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-13 |