BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 2103825 · Received May 18, 2011

    Report

    Report Number
    2183996-2011-01419
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT'S HUSBAND REPORTED THE PT IS CURRENTLY IN THE HOSP BECAUSE HER KIDNEYS FAIL. HUSBAND STATED HE DOESN'T KNOW IF HER DIABETES HAD ANYTHING TO DO WITH IT OR NOT BUT THE PT WAS WEARING THE INFUSION DEVICE AT THE TIME. HUSBAND REPORTED THE PT IS CURRENTLY NOT ON PUMP THERAPY AND THEY HAVE HER ON AN INSULIN SLIDING SCALE FOR HER DIABETES AT THE HOSP. ON FOLLOW-UP CALL ON (B)(6) 2011, PT'S HUSBAND REPORTED THE PT WAS HOSPITALIZED ON (B)(6) 2011. THE HUSBAND STATED PT HAD BEEN EXPERIENCING ELEVATED READINGS AND BLEEDING WITH THE INFUSION SETS. THE HUSBAND REPORTED THE PT WAS HOSPITALIZED WITH BACK PAIN, HER LIPS WERE TURNING BLUE AND HER BLOOD PRESSURE HAD DROPPED. HUSBAND STATED THE PT HADN'T BEEN HAVING ANY CONCERNS WITH READINGS OR THE INFUSION DEVICE THE DAY SHE WAS HOSPITALIZED. HUSBAND REPORTED HE COULD NOT SAY WHAT CAUSED THE KIDNEYS TO COLLAPSE. HUSBAND STATED THE PT WAS VERY NAUSEATED AND HAD ASPIRATED INTO HER LUNGS. THE HUSBAND REPORTED THE PT HAD BEEN HAVING ERRATIC READINGS AND BLEEDING AT THE INFUSION SITE WHILE USING THE INFUSION SETS BUT JUST NOT THE DAY OF THE HOSPITALIZATION. THE HUSBAND REPORTED THE PT'S BLOOD GLUCOSE LEVELS WERE UP TO 300-350 MG/DL AND THEN WOULD DROP DOWN TO 87-97 MG/DL FOR NO APPARENT REASON. PT'S TARGET BLOOD GLUCOSE RANGE IS 97-130 MG/DL. THE HUSBAND STATED THE PT WOULD BOLUS TO HELP BRING THE READINGS DOWN. THE HUSBAND REPORTED THE PT WOULD EAT A LITTLE FOOD TO BRING THE READINGS BACK UP WHEN HER READINGS DROPPED. THE HUSBAND STATED SHE WOULD CHANGE HER INFUSION SITE AND BLOOD WOULD START COMING OUT OF THE SITE. THE HUSBAND REPORTED THIS OCCURRED WITH EVERY INFUSION SET SHE CHANGED. THE HUSBAND STATED THERE WERE NO OUTSIDE INFLUENCES TO CAUSE PRESSURE ON THE INFUSION SITE. PT DISCARDED THE ALLEGED INFUSION SETS. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 32486170

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R INSULIN INFUSION PUMP| INSULIN