MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-15 for LABORATORY CORPORATION DNA ANALYSIS MACHINE * manufactured by Laboratory Corp Of America.
[291977]
Reporter took test with a lab, reporter believes the machines did not test the test properly. Reporter has reason to believe the lab copy results were from another dna lab. The test was done with reporter's significant other. Please check systems for accuracy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029331 |
| MDR Report Key | 479348 |
| Date Received | 2003-08-20 |
| Date of Report | 2003-08-15 |
| Date of Event | 2003-04-08 |
| Date Added to Maude | 2003-08-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABORATORY CORPORATION DNA ANALYSIS MACHINE |
| Generic Name | DNA MACHINE |
| Product Code | LNJ |
| Date Received | 2003-08-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 468189 |
| Manufacturer | LABORATORY CORP OF AMERICA |
| Manufacturer Address | * BURLINGTON NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-20 |