FDA.reportPublic FDA data

MAUDE MDR 1028760

MDR report key
1028760
Report number
2916283-2008-00003
Event key
0
Event type
3
Date of event
2008-01-11
Date received
2008-04-14
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
NORA ZEROUNIAN, GROUP MGR
Address
200 S. KRAEMER BLVD. P.O BOX 8000, MAIL STOP: W-110
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ICON 20 HCGQUALITATIVE HCG TESTBECKMAN COULTER, INC.JHJNA395097167H11N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-04-140

Event Narratives#

D

Patient 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING DISCREPANT NEGATIVE (-) URINE TEST RESULTS FROM THE ICON 20 HCG TEST KIT FOR FIVE DIFFERENT PT SAMPLES. PATIENT 1: A URINE SAMPLE TESTED WITH THE ICON 20 HCG TEST KIT GAVE A NEGATIVE (-) RESULT. A SERUM QUANTITATIVE TEST WAS 42344 (UNITS UNKNOWN) AND AN ULTRASOUND TEST ALSO WAS POSITIVE (+). THE PT WAS APPROX 8 WEEKS PREGNANT. PATIENT 2: A URINE SAMPLE TESTED WITH THE ICON 20 HCG TEST KIT GAVE A NEGATIVE (-) RESULT. AN ULTRASOUND TEST WAS POSITIVE (+) AND PT WAS APPROX 7 WEEKS PREGNANT. PATIENT 3: A URINE SAMPLE TESTED WITH THE ICON 20 HCG TEST KIT GAVE A NEGATIVE (-) RESULT. A HOME PREGNANCY TEST WAS POSITIVE (+), SERUM QUANTITATIVE TEST WAS 3751 (UNITS UNKNOWN) AND AN ULTRASOUND TEST ALSO WAS POSITIVE (+). THE PT WAS APPROX 6 WEEKS PREGNANT. PATIENT 4: A URINE SAMPLE TESTED WITH THE ICON 20 HCG TEST KIT GAVE A NEGATIVE (-) RESULT. A HOME PREGNANCY TEST AND ANOTHER QUALITATIVE PREGNANCY TEST WERE POSITIVE (+). PATIENT 5: A URINE SAMPLE TESTED WITH THE ICON HCG TEST KIT GAVE A NEGATIVE (-) RESULT. A HOME PREGNANCY TEST AND AN ULTRASOUND TEST WERE POSITIVE (+). THE PT WAS 10 WEEKS PREGNANT. NO AFFECT TO PT HAS BEEN REPORTED AS A RESULT OF THIS EVENT.

N

Patient 1

RETAIN DEVICES PERFORMED AS EXPECTED WHEN TESTED BY BECKMAN COULTER INC. (BCI) WITH: POSITIVE AND NEGATIVE SERUM AND URINE CONTROLS. POSITIVE CLINICAL URINE SAMPLE. BCI WAS NOT ABLE TO CONDUCT AN INVESTIGATION AS PT SAMPLES AND PRODUCT WERE NOT RETURNED BY THE CUSTOMER. BASED ON AVAILABLE INFO, CUSTOMER WAS USING LIQUID URINE CONTROLS WHICH ARE NOT VALIDATED FOR USE WITH THE ICON 20 HCG TEST KIT. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.