MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-05-10 for THIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS * 97-015 manufactured by Third Wave Technologies, Inc..
[449324]
The lab indicated that 2 false positive results (a het call for the r347p and 3849-10kb assays) were reported to the ordering physicians. Upon retesting of dna from the original samples, the results reported on 2/15/06 were discovered to have been false-positive and the physicians were notified by the lab using amended reports and by telephone. The false positive results were used for pt counseling which led to the physician ordering a cf carrier screening test on a pt's spouse. The lab received the blood specimen but testing was cancelled before results were obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134294-2006-00006 |
| MDR Report Key | 689739 |
| Report Source | 05,06 |
| Date Received | 2006-05-10 |
| Date of Report | 2006-03-20 |
| Date of Event | 2006-02-15 |
| Date Mfgr Received | 2006-03-10 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-03-21 |
| 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, RAC, EXEC. DIR. |
| Manufacturer Street | 502 S ROSA RD |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS |
| Generic Name | CFTR INPLEX AMPLIFICATION REAGENTS |
| Product Code | NUA |
| Date Received | 2006-05-10 |
| Model Number | * |
| Catalog Number | 97-015 |
| Lot Number | 02160782 |
| ID Number | * |
| Device Expiration Date | 2006-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 678913 |
| Manufacturer | THIRD WAVE TECHNOLOGIES, INC. |
| Manufacturer Address | 502 SOUTH ROSA RD. MADISON WI 53719 US |
| Baseline Brand Name | THIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS |
| Baseline Generic Name | CFTR INPLEX AMPLIFICATION REAGENTS |
| Baseline Model No | * |
| Baseline Catalog No | 97-015 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-05-10 |