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 FACTOR II (G20210A) BIPLEX FORMAT * 95-313 manufactured by Third Wave Technologies, Inc..
[18168759]
Patient sample was tested at medical center 3 times with the invader asr on 1/24/06. The initial result was a heterozygous (het) genotype call followed by two wild type (wt) calls in separate runs. The lab director believed the het result was due to an abnormally large amount of dna used based on the signal strength. In other words, the discrepant result was likely due to technologist error rather than instrument or assay-specific error. The clincian submitted an additional blood sample from the patient for testing the new result was a wt genotype call.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134294-2006-00001 |
| MDR Report Key | 686156 |
| Report Source | 05 |
| Date Received | 2006-05-10 |
| Date of Report | 2006-03-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SAM RUA, RAC 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 | FACTOR II (G20210A) BIPLEX FORMAT |
| Generic Name | ANALYTE SPECIFIC REAGENT |
| Product Code | MVU |
| Date Received | 2006-05-10 |
| Model Number | * |
| Catalog Number | 95-313 |
| Lot Number | 02121358 |
| 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 | 675380 |
| Manufacturer | THIRD WAVE TECHNOLOGIES, INC. |
| Manufacturer Address | 502 SOUTH ROSA ROAD MADISON WI 53719 US |
| Baseline Brand Name | FACTOR II (G20210A) BIPLEX FORMAT |
| Baseline Generic Name | ANALYTE SPECIFIC REAGENT |
| Baseline Model No | * |
| Baseline Catalog No | 95-313 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-05-10 |