BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1860031 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-05911
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 28, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    NEEDLE BROKE INTO THE SKIN [NEEDLE ISSUE]. NEEDLE REMAINED IN HIS THIGH AND PRESENTS WITH HEMATOMA ON THE THIGH [INJECTION SITE HEMATOMA]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFO: CLASS IIA. THIS SPONTANEOUS REPORT WAS RECEIVED FROM (B)(6) AND REPORTED BY A DIABETES NURSE SPECIALIST AS "NEEDLE REMAINED IN HIS THIGH AND PRESENTS WITH HEMATOMA ON THE THIGH" AND "NEEDLE BROKE INTO THE SKIN". IT CONCERNS A (B)(6), MALE, TREATED WITH NOVOFINE 8MM 30G (NEEDLE) SINCE (B)(6) 2010 AND ONGOING FOR "TYPE 2 DIABETES MELLITUS". PATIENT'S HEIGHT: 170 CENTIMETERS. MEDICAL HISTORY INCLUDES TYPE 2 DIABETES SINCE 2002, PULMONARY PROBLEMS, MULTIPLE ALLERGIES AND OSTEOPOROSIS. ON AN UNSPECIFIED DATE WHEN THE PT WAS HOSPITALIZED DUE TO PULMONARY PROBLEMS (NOT IN RELATION TO THE REPORTED EVENTS), HE EXPERIENCED THAT THE NEEDLE BROKE WHILE INJECTION WAS PERFORMED. THE PT INJECTED CORRECTLY INTO SKIN FOLD, BUT WHEN HE REMOVED THE NEEDLE HE FELT A SLIGHT PINCH AND AFTER HAVING DROPPED THE CUTANEOUS FOLD HE INTENDED TO PUT THE CAP BACK ON THE NEEDLE HE NOTICED THAT THE NEEDLE WAS NOT PRESENT. AS A CONSEQUENCE THE PT PRESENTED WITH HAEMATOMA AT THE INJECTION SITE AND THE NEEDLE HURTS UNDER MOVEMENT. THE PT UNDERWENT AN X-RAY EXAMINATION OF THE THIGH AND THE NEEDLE WAS LOCATED. AN ULTRASOUND WAS ALSO PERFORMED AND A DOCTOR TRIED TO EXTRACT THE NEEDLE WITH A MAGNETIC NEEDLE, BUT WITHOUT SUCCESS. THE PT IS A TRAINED USER OF NOVOFINE NEEDLES. HE PERFORMS AIR SHOTS PRIOR TO EACH INJECTION. A FUNCTION CHECK WAS PERFORMED AND THE DEVICE PASSED THE TEST. THE PT INJECTS NOVORAPID (RAPID ACTING INSULIN ASPART) 3 TIMES DAILY AND CHANGES THE NEEDLE ONCE DAILY. THE NEEDLE WAS STORED ACCORDING TO RECOMMENDATIONS. THE PT HAS NEVER BEFORE EXPERIENCED SUCH EVENTS WHILE USING NOVOFINE NEEDLES. THE REMAINS OF THE NEEDLE WAS RETURNED FOR INVESTIGATION. THE OUTCOME WAS REPORTED AS "UNKNOWN". REPORTER COMMENT: COMMENT BY THE REPORTER: THE PT'S EVOLUTION WILL LEAD TO EITHER FIBROSIS DUE TO THE FOREIGN BODY OR TO A REJECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 12 MINUTES: 205 MG/DL, 79 MG/DL, AND 209 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 20725542

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR NOVOLIN R