BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFIN 6 MM (30G) (NEEDLE) N/A

    MDR report key: 1893940 · Received November 2, 2010

    Report

    Report Number
    9681821-2010-00036
    Event Type
    Other
    Date Received
    November 2, 2010
    Date of Event
    June 1, 2009
    Report Date
    October 7, 2010
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INJECTION SITE BLACKENING [INJECTION SITE DISCOLORATION], INJECTION SITE OOZING [INJECTION SITE EXTRAVASATION], AT SITES OF INJECTIONS EMERGENCE IN THE ARM, ABDOMEN AND THIGHS RED HALOS OOZING, BLACKENED, LEAVING [INJECTION SITE ERYTHEMA]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFO: CLASS IIA. THIS SPONTANEOUS REPORT REC'D FROM (B)(6) AND REPORTED BY A MEDICAL DOCTOR AS "AT SITES OF INJECTIONS EMERGENCE IN THE ARM, ABDOMEN AND THIGHS RED HALOS OOZING, BLACKENED, LEAVING". IT CONCERNS A (B)(6) MALE PT, TREATED WITH MIXTARD 30 HM PENFILL (INSULIN HUMAN) FROM 1999 TO (B)(6) 2010 FOR "TYPE 1 DIABETES MELLITUS" AND NOVOFINE 6 MM (30G) NEEDLE FROM AND TO UNK DATES FOR DEVICE THERAPY. PT HEIGHT: (B)(6). MEDICAL HISTORY INCLUDED TYPE I DIABETES MELLITUS SINCE 1999. THE PT HAS NO OTHER MEDICAL HISTORY AND HAS NEVER CONSUMED ALCOHOL AS HE IS A PRACTICING (B)(6). THE MOTHER OF THE PT IS DIABETIC TOO. A (B)(6) PT WITH TYPE I DIABETES, STARTED TREATMENT WITH MIXTARD 30 HM PENFILL IN 1999, WITH THREE INJECTIONS A DAY 30UI-30UI-30UI. SINCE (B)(6) 2009, THE PT EXPERIENCED AT SITES OF INJECTIONS EMERGENCE IN THE ARM, ABDOMEN AND THIGHS RED HALOS OOZING, BLACKENED, LEAVING NECROTIC SEQUELAE ON ROOTS W/O NODULES. FOLLOWING THIS EVENT, THE PT HAS BEEN SWITCHED TO NOVOMIX 30 ON (B)(6) 2010. THE DERMATOLOGIST PRESCRIBED OXACILLIN FOR THE EVENT, BUT THE PT WAS TREATED WITH AMOXYCILLIN. THE EVENT OCCURRED IN (B)(6) 2009 AND THE EVENT STOPPED ON (B)(6) 2010. THE OVERALL OUTCOME IS REPORTED AS "RECOVERED WITH SEQUELAE". THE SEQUELAE ARE OLD LESIONS WITH PRODUCTION OF PUS. NO NEW LESIONS AT INJECTION SITE AFTER THE SWITCH. THE PT IS A TRAINED USER, DURING THE HOSPITALIZATION IN 1999 WHEN DIABETES WAS DIAGNOSED, HE REC'D THE TRAINING. HE PERFORMS AIR SHOTS PRIOR TO THE FIRST INJECTION FOR A NEW CARTRIDGE, STORES THE MIXTARD IN REFRIGERATOR DURING USE AND RE-USES THE NEEDLES. THE PT STARTED USING NOVOFINE NEEDLES RECENTLY, PRIOR TO THEM, HE USED SOME NEEDLES IN (B)(6) (NAME OR TYPE NOT PROVIDED). ON (B)(6) 2010, SAMPLES WERE REC'D IN NN. COMMENT: COMPANY COMMENT: INJECTION SITE REACTIONS CAN OCCUR DUE TO: FAULTY INJECTION TECHNIQUE, USE OF BAD NEEDLE, SKIN RUBS AFTER INSULIN INJECTION, HYPERSENSITIVITY AND BAD COAGULATION. TO MINIMIZE THE RISK OF INJECTION SITE REACTION, ALL NOVO NORDISK NEEDLES ARE RECOMMENDED TO BE USED ONLY FOR ONE INJECTION. ANY DEVIATIONS FROM THE INSTRUCTION MANUAL RECOMMENDED BY NOVO NORDISK MAY CAUSE THE DAMAGE OF NEEDLE; AS A CONSEQUENCE THIS CAN RESULT IN POTENTIAL INJURY TO THE PT. IN THIS CASE, THE PT EXPERIENCED THE RED HALOS OOZING AND BLACKEN AT INJECTION SITE. THE PT RE-USED THE NEEDLES, WHICH MAY PROVIDE A POTENTIAL EXPLANATION FOR THE OCCURRENCE OF INJECTION SITE REACTION. RPTR COMMENT: RPTR ALTERNATIVE AETIOLOGY. NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFIN 6 MM (30G) (NEEDLE) N/A NEEDLE FMI NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other LOT # X561497, EXP DATE 08/2011| DOSE, FREQUENCY & ROUTE USED: 90 U, QD| FOR INJECTION, 100IU/ML| MIXTARD 30 HM PENFILL(INSULIN HUMAN) SUSPENSION