FDA.reportPublic FDA data

MAUDE MDR 7215853

MDR report key
7215853
Report number
2027969-2018-00006
Event key
0
Event type
3
Date received
2018-01-24
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
YA-LING KING
Address
9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US
Phone
858-858-8588
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MULTI-DRUG 4 PANEL SCREEN TESTENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITESALERE SAN DIEGO, INC.DIODOA-344DOA7030237R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-240

Event Narratives#

N

Patient 1

INVESTIGATION CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION PRODUCTS. RETENTION DEVICES WERE TESTED WITH IN-HOUSE DRUG-FREE DONOR URINE AND ALL DEVICES SHOWED EXPECTED NEGATIVE RESULTS FOR ALL ANALYTES INCLUDING COC, MAMP (MET), THC, AND MOP ANALYTES AT THE READ TIME. NO FALSE POSITIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

D

Patient 1

THE CUSTOMER REPORTED RECEIVING TWENTY-THREE UNCONFIRMED FALSE POSITIVE RESULTS FOR ALL ANALYTES ON A BOX OF MULTI-DRUG 4 PANEL (COC/MAMP/THC/MOP) SCREEN TESTS. NO CONFIRMATORY TESTING WAS CONDUCTED. ONE OF THE TESTS THE CUSTOMER CONDUCTED ON HERSELF.