BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL SP HCG COMBO

    MDR report key: 1053247 · Received May 28, 2008

    Report

    Report Number
    3005689981-2008-00022
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 28, 2008
    Manufacturer
    INNOVACON
    Product Code
    LCX
    PMA / PMN Number
    062361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION DEVICE TESTING. SUMMARY OF RESULTS: THE RETENTION DEVICES MEET QC SPECIFICATION. CORRECT POSITIVE RESULTS WERE OBSERVED WHEN TESTED WITH 20MIU/ML HCG URINE CONTROL AT 3 MINS READ TIME. THE 100MIU/ML AND 248.57IU/ML HCG URINE CONTROL YIELDED CLEARLY POSITIVE RESULTS AT 3 MINS READING TIME. PROBABLE ROOT CAUSE: IT IS STATED IN THE COMPLAINT INFO THAT THE PT IS 17-18 WEEKS PREGNANT IN 2008, SO, THE PT IS 9-10 WEEKS PREGNANT APPROX TWO MONTHS PRIOR, 14-15 WEEKS PREGNANT ON EIGHTEEN DAYS PRIOR TO ORIGINAL DATE, AND 16-17 WEEKS PREGNANT ON A WEEK PRIOR TO ORIGINAL DATE. AT THAT TIME HOOK EFFECT MAY WEAKEN THE T LINE INTENSITY BECAUSE OF VERY HIGH HCG LEVEL. FURTHER INVESTIGATION WILL BE TAKEN IF THE PT SAMPLE IS AVAILABLE. CONCLUSION: THE RETENTION DEVICES MEET QC SPECIFICATION. NO FALSE NEGATIVE RESULT WAS OBSERVED. SO THIS COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    A FEMALE PT CAME TO OUR ED ON THREE SEPARATE OCCASIONS COMPLAINING OF BACK AND STOMACH ACHE PAIN POSSIBLE KIDNEY STONES AND HAD A URINE PREGNANCY TEST PERFORMED. ON ALL THREE OCCASIONS THE PT HAD NEGATIVE PREGNANCY TESTS REPORTED. THE PT CAME IN THREE TIMES IN 2008. THE PT CAME IN AGAIN A WEEK AFTER THE THIRD TIME, AND HAD AN ULTRA SOUND STUDY OF HER ABDOMEN AND THE RADIOLOGIST REPORTED THAT A 16-17 WEEK LIVING FETUS WAS PRESENT. THE PRODUCT USED FOR THE PREGNANCY TEST IS THE HCG COMBO SP BRAND RAPID TEST. THE PRODUCT LOT NUMBER IS HCG8010142 EXPIRATION DATE JAN. 2010. I LOOKED AT THE URINALYSIS PERFORMED ON THE THREE UA'S IN QUESTION AND TWO WERE TURBID WITH MANY WBC'S AND BACTERIA PRESENT.ONE WAS HAZY WITH MANY WBC'S AND BACTERIA PRESENT. SP. GRAVITY ON ONE SPECIMEN WAS 1.008 AND THE OTHERS WERE 1.014. THIS PT HAD A DRUG SCREEN PERFORMED IN 2007 THAT WAS POSITIVE FOR COCAINE AND OPIATES AND DIAZPBENZEDINES. THE LAST ONE I PROBABLY DIDN'T SPELL RIGHT. ANYWAY KNOWING THE ABOVE INFO WHAT COULD BE INTERFERING OR COULD BE THE CAUSE OF A FALSE NEGATIVE RESULT. WE NO LONGER HAVE THE SPECIMENS AND ARE CONTACTING THE ATTENDING TO SEE IF WE CAN GET ANOTHER SPECIMEN TO TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL SP HCG COMBO ONE STEP PREGNANCY TEST (URINE/SERUM) LCX INNOVACON FHC-A202-KCA30 HCG8010142

    Patients

    Seq Age Sex Outcome Treatment
    1