MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-10 for INVADER DNA ASSAY CONTROLS; FACTOR II (G20210A) * 98-312 manufactured by Third Wave Technologies, Inc..
[461306]
Patient sample was tested at medical center 3 times with the invader asr in 1/06. The initial result was a heterozygous (het) genotype call followedby two wild type (wt) calls in separated runs. The lab director, indicated that the initial results prompted the clinician to subject the patient to additional sample collection. The director further indicated the therapeutic management of this patient was not adversely affected by the initial false positive report to the clinician. The second sample from this patient was tested by the same laboratory with no discrepant results. The clinician was promptly notified of the secondary results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134294-2006-00003 |
| MDR Report Key | 686221 |
| Report Source | 05 |
| Date Received | 2006-05-10 |
| Date of Report | 2006-05-10 |
| Date of Event | 2006-02-23 |
| Date Mfgr Received | 2006-02-23 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-03-15 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | SAM RUA, EXEC. DIRECTOR |
| Manufacturer Street | 502 S. ROSA ROAD |
| Manufacturer City | MADISON WI 53719 |
| Manufacturer Country | US |
| Manufacturer Postal | 53719 |
| Manufacturer Phone | 6082042966 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVADER DNA ASSAY CONTROLS; FACTOR II (G20210A) |
| Generic Name | ANALYTE SPECIFIC REAGENT |
| Product Code | MVU |
| Date Received | 2006-05-10 |
| Model Number | * |
| Catalog Number | 98-312 |
| Lot Number | 02121365 |
| ID Number | * |
| Device Expiration Date | 2006-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 675446 |
| Manufacturer | THIRD WAVE TECHNOLOGIES, INC. |
| Manufacturer Address | 502 SOUTH ROSA ROAD MADISON WI 53719 US |
| Baseline Brand Name | INVADER DNA ASSAY CONTROLS; FACTOR II (G20210A) |
| Baseline Generic Name | ANALYTE SPECIFIC REAGENT |
| Baseline Model No | * |
| Baseline Catalog No | 98-312 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-05-10 |