FDA.reportPublic FDA data

MAUDE MDR 3815352

MDR report key
3815352
Report number
2027969-2014-00277
Event key
0
Event type
3
Date of event
2014-02-27
Date received
2014-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
YA KING
Address
9975 SUMMERS RIDGE RD 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 DS-7TRIAGE TOX DS-7ALERE SAN DIEGO, INC.DJR94404W56062RBY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-270

Event Narratives#

D

Patient 1

CALLER REPORTING FALSE POSITIVE FOR COCAINE. THE CUSTOMER RAN ONE PATIENT SAMPLE AND RECEIVED POSITIVE RESULTS ON ALL 7 DRUGS; AMP, MAMP, BAR, BZO, COC, OPI AND TRC FOR ONE CLOUDY PATIENT URINE SAMPLE. THE CUSTOMER QUESTIONED THE RESULT AND NOTICED THE SAMPLE WAS CLOUDY. SHE SPUN THE SAMPLE DOWN, REPEATED IT WITHIN ABOUT 5 MINUTES OF THE INITIAL POSITIVE RESULT, AND RECEIVED A NEGATIVE RESULT FOR ALL DRUGS. THE LAB ORIGINALLY REPORTED THE POSITIVE RESULTS, BUT THE CALLER CORRECTED THE REPORTS MINUTES LATER AND REPORTED NEGATIVE FOR ALL DRUGS AFTER REPEATING THE SAMPLE. THE URINE SAMPLE WAS FRESH AND VOIDED INTO A PLASTIC CONTAINER. URINALYSIS SHOWED 30 MG/DL PROTEIN, LARGE OCCULT BLOOD, LARGE LEUKOCYTE ESTERASE, A FULL FIELD OF WHITE CELLS, AND FEW BACTERIA. THE PATIENT WAS A HEART PATIENT IN HIS 60'S WITH A URINARY TRACT INFECTION. NO CONFIRMATORY TESTING WAS DONE ON THE SAMPLE. THERE ARE NO OTHER QUESTIONABLE PATIENT SAMPLES AND THE CUSTOMER IS NOT QUESTIONING THIS LOT. QC WAS RUN 2/24 AND IT PRODUCED EXPECTED RESULTS. THE CUSTOMER STORED THE SAMPLE IN THE FRIDGE AND AGREED TO SEND IT TO ALERE IF WER WOULD LIKE TO HAVE THE SAMPLE FOR INVESTIGATION. THE CUSTOMER IS AWARE THAT IT HAS BEEN STORED IN THE FRIDGE FOR LONGER THAN IT STATES IN THE PI, BUT OFFERED TO SEND IT FOR INVESTIGATION.

N

Patient 1

DATA RESULTS FROM RETURNED PATIENT SAMPLE WERE NEGATIVE FOR ALL ANALYTES ON THE TRIAGE TOX DS-7 PANEL. NO POSITIVE RESULTS WERE OBSERVED WITH ANY DEVICES TESTED. RESULTS OF FURTHER ANALYSIS OF THE RETURNED PATIENT SAMPLE WITH SIEMEN'S MULTISTIX SHOWED EVIDENCE OF BLOOD IN THE SAMPLE. SAMPLE ABNORMALITIES SUCH AS BLOOD ARE KNOWN TO CAUSE DISCREPANT RESULTS. THIS CANNOT BE RULED OUT AS A POSSIBLE CAUSE FOR THE CUSTOMER'S OBSERVATIONS. AS OF 03/20/2014 THIS IS THE ONLY COMPLAINT AGAINST TOX DS-7 LOT W56062. NO PRODUCT DEFICIENCY WAS ESTABLISHED. AS THERE IS NO INDICATION OF A PRODUCT DEFICIENCY, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.