TRIAGE TOX DRUG SCREEN WITH MTD 94400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2011-08-10 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Alere San Diego, Inc..

Event Text Entries

[2196772] Caller alleged false negative apap. Pt tested apap negative and opi positive. Pt is taking vicodin 5mg (hydrocodone) /500mg (apap), 1 qid. On (b)(6) 2011, urine was tested at 9:20am with tox w48841b, apap - and opi +. All controls passed ok. No abnormality was observed on urine sample. No urine sample was saved. No info on pt's clinical condition and diagnosis was provided. The lab is using tox to monitor pts treated with different drugs. Doctors just want to know if pts take the drug or not. No confirmatory test was done.
Patient Sequence No: 1, Text Type: D, B5


[9347768] Investigation pending.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2027969-2011-01775
MDR Report Key2251575
Report Source00,05
Date Received2011-08-10
Date of Report2011-08-10
Date of Event2011-04-04
Date Mfgr Received2011-07-11
Date Added to Maude2011-10-20
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 FDA0
Event Location0
Manufacturer ContactCARMEN BERGELIN, MGR
Manufacturer Street9975 SUMMERS RIDGE RD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8588052256
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIAGE TOX DRUG SCREEN WITH MTD
Generic NameDRUGS OF ABUSE TEST
Product CodeDJR
Date Received2011-08-10
Model Number94400
Lot NumberW48841B
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO, INC.
Manufacturer AddressSAN DIEGO CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2011-08-10

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