BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3040400 · Received April 8, 2013

    Report

    Report Number
    2183996-2013-00604
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE LEVEL WAS ELEVATED TO 343 MG/DL AT 8:10PM ON (B)(6) 2013 AND SHE BLOUSED 12.5 UNITS OF INSULIN. 2 HOURS LATER, HER BLOOD GLUCOSE LEVEL WAS 453 MG/DL AND SHE BLOUSED AGAIN. HER TARGET RANGE IS 80-120 MG/DL. THE PATIENT'S BLOOD GLUCOSE LEVEL CONTINUED TO ELEVATE TO 560 MG/DL. THE PATIENT ADMINISTERED 12 UNITS OF INSULIN VIA INJECTION. SHE CHANGED HER INFUSION SET AND FOUND THAT HER CANNULA WAS BENT. AFTER CHANGING HER INFUSION SET, HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. FOLLOW-UP WITH THE PATIENT ON (B)(6) 2013 REVEALED THAT THE PATIENT THINKS THE INFUSION DEVICE SHOULD HAVE PROVIDED AN ALARM OR ERROR MESSAGE AND IT NEVER DID. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE AND INFUSION SET WERE REPLACED. THE USED INFUSION SET WAS DISCARDED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143451 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR NOVOLOG (PEN)| NOVOLOG (PUMP)| AVIVA COMBO METER| INSULIN PEN (NOVOLOG)