THIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS * 97-015

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number2134294-2006-00006
MDR Report Key689739
Report Source05,06
Date Received2006-05-10
Date of Report2006-03-20
Date of Event2006-02-15
Date Mfgr Received2006-03-10
Device Manufacturer Date2005-12-01
Date Added to Maude2006-03-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactSAM RUA, RAC, EXEC. DIR.
Manufacturer Street502 S ROSA RD
Manufacturer CityMADISON WI 53719
Manufacturer CountryUS
Manufacturer Postal53719
Manufacturer Phone6082042966
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS
Generic NameCFTR INPLEX AMPLIFICATION REAGENTS
Product CodeNUA
Date Received2006-05-10
Model Number*
Catalog Number97-015
Lot Number02160782
ID Number*
Device Expiration Date2006-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key678913
ManufacturerTHIRD WAVE TECHNOLOGIES, INC.
Manufacturer Address502 SOUTH ROSA RD. MADISON WI 53719 US
Baseline Brand NameTHIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS
Baseline Generic NameCFTR INPLEX AMPLIFICATION REAGENTS
Baseline Model No*
Baseline Catalog No97-015
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-05-10

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