FDA.reportPublic FDA data

MAUDE MDR 6437326

MDR report key
6437326
Report number
2027969-2017-00053
Event key
0
Event type
3
Date of event
2017-02-28
Date received
2017-03-27
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
1TRIAGE TOX DRUG SCREEN PANELENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITESALERE SAN DIEGO, INC.DIO94400EUW62368RBR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-270

Event Narratives#

N

Patient 1

INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF A FALSE POSITIVE COCAINE WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAINS OF LOT W62368. MANUFACTURING BATCH RECORDS FOR LOT W62368 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. 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 A FALSE POSITIVE COCAINE RESULTS ON A (B)(6) INFANT. THE MOTHER WAS REPORTED AS TAKING SUBUTEX WHICH CONTAINS BUPRENORPHINE. NO CONFIRMATORY TESTING WAS CONDUCTED. THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO K060791.