FDA.reportPublic FDA data

MAUDE MDR 1006618

MDR report key
1006618
Report number
3005689981-2008-00013
Event key
0
Event type
3
Date of event
2008-01-11
Date received
2008-03-04
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#

Address
4106 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US
Phone
858-858-8582
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HENRY SCHEIN ONE STEP + HCG DIPSTICKONE STEP PREGNANCY TEST (URINE)INNOVACON, INC.JHJFHC-101-KHS25HCG7090098NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-03-040

Event Narratives#

D

Patient 1

IN 2008, A WOMAN DID AN EPT TEST AND THE RESULT WAS POSITIVE. LAUREN HAD THIS WOMAN COLLECT A URINE SPECIMEN AROUND 2 PM AND LAUREN TESTED THIS SPECIMEN ON HENRY SCHEIN URINE HCG RAPID DIPSTICK TEST. RESULT WAS NEGATIVE. THE WOMAN WENT TO HER OB/GYN THAT SAME DAY AROUND 6 PM WHERE THEY DID A URINE TEST (RESULT POSITIVE) AND A SERUM TEST (RESULT POSITIVE). IT WAS UNKNOWN IF IT WAS A SERUM QUALITATIVE OR QUANTITATIVE THAT WAS PERFORMED. QC IS WORKING FINE AND SEEING A CONTROL LINE WITH EACH...

N

Patient 1

RETENTION DEVICE TESTING PERFORMED. THE RETENTION DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 25 MIU/ML HCG URINE CONTROL. THE 100 MIU/ML 10 IU/ML AND 213.2 IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINUTES READING TIME. PROBABLE ROOT CAUSE: THE URINE HCG LEVEL ALWAYS LOWER THAN SERUM AS THE URINE SAMPLE IS MORE LIKELY INFLUENCED BY MANY FACTORS. IF THE PATIENT DRINKS TOO MUCH WATER WHICH WILL DILUTE THE URINE BEFORE THE TEST, THE URINE MAY NOT CONTAIN REPRESENTATIVE LEVELS OF HCG AND A FALSE NEGATIVE RESULTS MAY BE OBTAINED. AS SO, IF PREGNANCY IS SUSPECTED, A FIRST MORNING URINE SPECIMEN SHOULD BE COLLECTED AND TESTED. CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED. MANUFACTURING DOCUMENTATION FOR THIS LOT NUMBER WAS REVIEW. NO ABNORMALITY HAD BEEN OBSERVED.