Description of Event or Problem · 1
A PT WHO HAD A POSITIVE HOME PREGNANCY TEST ON 11/6/96 HAD HER URINE TESTED THE NEXT DAY USING THE HCG URINE ASSAY LN 690625. THE RESULT OF THE TEST WAS NEGATIVE. THE TEST WAS REPEATED USING THE SAME URINE SAMPLE WITH NEGATIVE RESULTS. A SERUM SAMPLE WAS DRAWN WITH A RESULT OF 744 MIU/ML HCG(METHOD USED ANOTHER BRAND). AN ULTRASOUND WAS PERFORMED ON 11/13/96 AND INDICATED A NORMALLY PROGRESSING PREGNANCY. THE PT IS A 34 YEARS OLD AND UNDERGOING FERTILITY TREATMENT. AN OPENED KIT LOT NUMBER 690625 WAS RETURNED FROM THE CUSTOMER FOR IN-HOUSE TESTING. NO SAMPLE WAS RETURNED. NEGATIVE CONTROL, POSITIVE CONTROL AND POSITIVE CONTROL DILUTIONS WERE TESTED USING THE RETURNED KIT. TESTING RESULTS WERE ACCEPTABLE. SAMPLE NEGATIVE CONTROL, HCG CONCENTRATIONS MIU/ML 0, RETURNED KIT RESULTS VISUALLY NEGATIVE. SAMPLE POSITIVE CONTROL (PC), HCG CONCENTRATIONS MIU/ML 50, RETURNED KIT RESULTS VISUALLY POSITIVE. SAMPLE 1:2 DILUTION OF PC, HCG CONCENTRATION MIU/ML 25, RETURNED KIT RESULTS VISUALLY POSITIVE. SAMPLE 1:5 DILUTION OF PC, HCG CONCENTRATION MIU/ML 10, RETURNED KIT RESULTS VISUALLY POSITIVE. SAMPLE 1:10 DILUTION OF PC, HCG CONCENTRATION MIU/ML 5, VISUALLY POSITIVE. BASED ON THE INFO OBTAINED BY CO TO DATE, NO DEATH OR SERIOUS INJURY HAS OCCURRED BECAUSE OF THIS POSSIBLE MALFUNCTION. CO HAS NO CURRENT PLANS TO SUBMIT ADD'L INFO PERTAINING TO THIS MEDICAL DEVICE REPORT.