Description of Event or Problem · 1
ON 7/15/97, SELFCARE, INC. RECEIVED A COMPLAINT FROM A CONSUMER WHO CLAIMED THAT SHE USED "SAVON STICK PREGNANCY TEST" [OTC MID-STREAM URINE TEST] ON THREE DIFFERENT OCCASIONS AND OBTAINED NEGATIVE RESULTS EACH TIME. FURTHERMORE, SHE CLAIMED THAT "HER PHYSICIAN LATER DIAGNOSED HAS AS BEING 8-12 WEEKS PREGNANT BASED ON BLOOD"[HCG LEVELS]. COMPLAINANT RECALLED FOLLOWING SEQUENCE OF EVENTS (APPROXIMATE DATES): 4/4 FIRST DAY OF LAST MENSTRUAL PERIOD. 5/23 USED PREGNANCY TEST AND OBTAINED NEGATIVE RESULT. 6/16 CONDUCTED 2ND PREGNANCY TEST AND OBTAINED NEGATIVE RESULT. 6/25 CONDUCTED 3RD PREGNANCY TEST AND OBTAINED NEGATIVE RESULT. 7/11 COMPLAINANT RECEIVED NOTICE FROM HER PHYSICIAN THAT SHE WAS "8-12 WEEKS PREGNANT" BASED ON BLOOD HCG LEVELS. COMPLAINANT REPORTED THAT SHE HAS A HISTORY OF CHRONIC KIDNEY DISEASE RESULTING IN "UPGJ OBSTRUCTION", "DECREASED RENAL FUNCTION" AND "CHRONIC BACTERIA IN KIDNEY". ACCORDING TO WOMAN, HER RENAL DISEASE IS SUCH THAT SHE CANNOT CARRY A PREGNANCY TO TERM WITHOUT APPROPRIATE PRE-NATAL MEASURES. SHE CLAIMED THAT THIS PREGNANCY MUST BE TERMINATED. COMPLAINANT FIRST CONTACT SELFCARE AFTER LEARNING FROM HER PHYSICIAN THAT SHE WAS 8-12 WEEKS PREGNANT. SHE WAS UPSET THAT THREE TESTS SHE PERFORMED WERE NEGATIVE WHEN SHE WAS ACTUALLY PREGNANT (I.E. "FALSE NEGATIVE"). SHE EXPRESSED CONCERN THAT DELAYED DIAGNOSIS WOULD LEAD TO AN ABORTION LATER INTO PREGNANCY. MFR'S ANALYSIS OF EVENT: CIRCUMSTANCES INVOLVED IN THIS COMPLAINT WERE HIGHLY UNUSUAL AND LEFT MANY QUESTIONS UNANSWERED. COMPLAINT INVESTIGATION WAS HAMPERED BY LACK OF SPECIFIC INFO ABOUT IMPLICATED PRODUCT (ALL TESTS AND LABELING WERE DISCARDED BY USER) AND LACK OF DIRECT MEDICAL INFO FROM THE WOMAN'S PHYSICIAN. FURTHERMORE, ONLY INFO AVAILABLE RESULTED FROM A SINGLE VERBAL REPORT FROM COMPLAINANT. SHE HAS NOT RETURNED F/U CALLS NOR HAS SELFCARE RECEIVED ANY WRITTEN LAB OR PHYSICIAN'S RESULTS. AS SUCH, "MEDICAL" STATEMENTS CONTAINED IN THIS REPORT SHOULD BE CONSIDERED INDIRECT INFO REPORTED FROM CONSUMER. COMPLAINANT REPORTEDLY USED PREGNANCY TEST ON THREE DIFFERENT OCCASIONS SPANNING A PERIOD OF 4.5 WEEKS. THAT INTERVAL ENCOMPASSED A TIME WHERE HER MENSTRUAL PERIOD WAS BETWEEN 3 TO 7.5 WEEKS LATE. DURING THIS TIME SHE WAS RELYING SOLELY ON HER SELF-TESTING FOR PREGNANCY WHILE FACED WITH AN EXTENDED DELAY IN HER MENSTRUAL PERIOD AND A SERIOUS MEDICAL CONDITION. THIS IS FIRST COMPLAINT OF THIS TYPE RECEIVED BY SELFCARE AFTER HAVING SOLD MILLIONS OF PREGNANCY TEST KITS OVER A PERIOD OF MANY YEARS. PRODUCT INSERT RECOMMENDS THAT USERS WHO OBTAIN NEGATIVE TEST RESULTS AND HAVE NOT STARTED THEIR PERIOD WITHIN 7 DAYS SHOULD "CONSULT THEIR DR". IN ADDITION, INSERT CAUTIONS USER TO "CHECK WITH YOUR DR IF YOU GET UNEXPECTED OR INCONSISTENT RESULTS" AS THERE ARE "CERTAIN HEALTH CONDITIONS" THAT "MAY CAUSE A FALSE OR IRREGULAR RESULT". AGAIN, IN THIS VERY UNUSUAL CASE, THE COMPLAINANT DID NOT SEEK MEDICAL ATTENTION UNTIL HER MENSTRUAL PERIOD WAS TEN WEEKS LATE.