FDA.reportPublic FDA data

MAUDE MDR 8656004

MDR report key
8656004
Report number
2024800-2019-00006
Event key
0
Event type
3
Date of event
2019-05-23
Date received
2019-05-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JULIETTE BUSSE
Address
10210 GENETIC CENTER DR. SAN DIEGO CA 92121 US
Phone
858-858-8584
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1APTIMA COMBO 2 ASSAYIN-VITRO DIAGNOSTICHOLOGIC, INC.LSL302661* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-3001. O

Event Narratives#

D

Patient 1

(B)(6), DEPARTMENT OF LABORATORY MEDICINE, CLINICAL MICROBIOLOGY, FACULTY OF MEDICINE AND HEALTH, (B)(6) REPORTED TWO APTIMA AC2 SAMPLES THAT HAD BEEN SEQUENCED AND CONFIRMED THE FINISH VARIANT THAT IS CURRENTLY UNDER INVESTIGATION BY HOLOGIC. THE FINISH VARIANT IS NOT PICKED UP BY THE APTIMA AC2 TEST GENERATING A CT/GC NEGATIVE RESULT, BUT IS POSITIVE IN AN APTIMA CT RE-TEST. AN ON-GOING INVESTIGATION AND RISK ASSESSMENT ARE IN PROCESS AT HOLOGIC REGARDING THIS COMPLAINT.