Description of Event or Problem · 0
WE HAVE HAD AT LEAST 7 INSTANCES OF FALSE NEGATIVE URINE POINT OF CARE PREGNANCY TESTS INVOLVING THE OSOM ULTRA HCG COMBO TEST. IN ONE INSTANCE, A FEMALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF NAUSEA, FATIGUE, AND ABDOMINAL PAIN. A POINT OF CARE URINE PREGNANCY TEST WAS PERFORMED USING THE OSOM ULTRA HCG COMBO TEST AND WAS NEGATIVE. THE PATIENT WAS SENT TO CT AND WAS LATER DETERMINED TO BE 6 WEEKS PREGNANT BY ULTRASOUND. THIS HAS CAUSED A MAJOR DISRUPTION AT OUR HOSPITAL AND USE OF THIS PRODUCT HAS BEEN DISCONTINUED ACROSS OUR 13-HOSPITAL SYSTEM. THE COMPANY HAS BEEN CONTACTED FOR A RESPONSE AND HAS ASKED FOR SOME OF THE DEFECTIVE PRODUCT TO BE RETURNED. WE BELIEVE THIS IS A MANUFACTURING ERROR AS A SINGLE PATIENT WITH A SIGNIFICANT HCG LEVEL TESTED POSITIVE ON SOME TESTS AND NEGATIVE ON OTHERS. THE SAME TEST KIT WAS USED IN OTHER DEPARTMENTS AT OUR HOSPITAL AND PRODUCED AT LEAST FOUR (4) ADDITIONAL FALSE NEGATIVE PREGNANCY RESULTS. IN ADDITION, THE REPRODUCTIVE ENDOCRINOLOGY CLINIC HAD FALSE NEGATIVE RESULTS ON TWO (2) PATIENTS. REPRODUCTIVE ENDOCRINOLOGY USES THE POC PREGNANCY TEST TO VERIFY A LACK OF PREGNANCY PRIOR AT THE TIME OF UTERINE PROCEDURES.