MAUDE MDR 2338098

MDR report key
2338098
Report number
2024674-2011-00002
Event key
0
Event type
3
Date of event
2011-04-01
Date received
2011-11-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
10165 MCKELLAR CT. SAN DIEGO CA 92121 US
Phone
858-858-8585
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1QUICKVUE DIPSTICK STREP A TEST KITQUICKVUE DIPSTICK STREP A TEST KITQUIDEL CORP.GTZNA20108UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-0701. O

Event Narratives#

D

Patient 1

MOTHER OF (B)(6) MALE REPORTED THE FOLLOWING EVENTS. THE PATIENT WAS BROUGHT TO MEDICAL FACILITY MULTIPLE TIMES WITH SYMPTOMS OF NAUSEA AND VOMITING OVER A THREE-MONTH PERIOD DURING (B)(6) 2011. PATIENT THROAT SWABS WERE TESTED 6-7 TIMES WITH THE QUICKVUE DIPSTICK STREP A TEST AND RECEIVED POSITIVE TEST RESULTS IN EACH CASE. PATIENT WAS ISSUED ANTIBIOTICS AFTER MORE THAN ONE VISIT (MAY INCLUDE AMOXICILLIN AND CLINDAMYCIN). MOTHER INDICATED THAT SHE BELIEVED THE FACILITY HAD PERFORMED BACK-UP CELL CULTURE ON MORE THAN ONE THROAT SPECIMEN TAKEN FROM THE PATIENT, AND THE CULTURES WERE NEGATIVE FOR GROUP A STREPTOCOCCUS. HOWEVER, SHE (AS THE PARENT) DID NOT RECEIVE FORMAL NOTIFICATION OF THESE CULTURE RESULTS FROM THE FACILITY. PATIENT WAS TAKEN TO AN INFECTIOUS DISEASE DOCTOR AND ENT DOCTOR, AND A TONSILLECTOMY WAS LATER PERFORMED ON (B)(6) 2011 DUE TO NO APPARENT RESPONSE TO CLINDAMYCIN TREATMENT. MOTHER INDICATED THAT THE PATIENT TESTED POSITIVE FOR STREP A SINCE THE TONSILLECTOMY, HOWEVER IT WAS NOT SPECIFIED IF THIS TESTING WAS PERFORMED WITH THE QUICKVUE TEST. NO OTHER DIAGNOSIS HAS BEEN MADE REGARDING THE PATIENT'S CONDITION.

N

Patient 1

MANUFACTURER ANALYZED COMPLAINT DATA FROM THE PREVIOUS THREE (3) YEARS. NO TREND WAS IDENTIFIED FOR FALSE POSITIVE TEST RESULTS WITH THE QUICKVUE DIPSTICK STREP A PRODUCT.