BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3242240 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01336
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    May 16, 2013
    Report Date
    August 9, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. PRODUCTION DATA WAS REVIEWED AND COMPLY WITH SPECIFICATIONS. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED. NO PRODUCT WAS RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT REQUESTED TO BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT ON (B)(6) 2013, HE HAD TO GO TO THE EMERGENCY ROOM DUE TO INSULIN SHOCK. ON (B)(6) 2013, THE PATIENT RETURNED HIS INFUSION DEVICE TO HAVE IT REPLACED FOR AN ELECTRONIC ERROR. THE PATIENT WAS UTILIZING INSULIN INJECTIONS DURING THAT TIME. HIS DOCTOR STATED HIS BODY WAS USED TO GETTING CONSTANT INSULIN AND WENT INTO SHOCK WHEN HE BEGAN ONLY GIVING HIMSELF INSULIN AT MEAL TIMES. THE PATIENT WAS INCOHERENT AND DOES NOT RECALL ANYTHING THAT HAPPENED LEADING UP TO HIM GOING TO THE EMERGENCY ROOM. THE PATIENT STATED THAT HE WAS ONLY OFF THE INFUSION DEVICE FOR 24 HOURS BEFORE HE WAS IN THE EMERGENCY ROOM. THE PATIENT STATED THAT HE HAD NEVER USED A SYRINGE TO GIVE HIMSELF INSULIN. HE DOES NOT KNOW IF HE DID IT CORRECTLY. HE WAS TEACHING AT SCHOOL AND HE WAS NOT FEELING WELL AND WENT TO THE SCHOOL NURSE. THE NURSE CHECKED HIS BLOOD GLUCOSE LEVEL AND CALLED PARAMEDIC TO TAKE HIM TO THE HOSPITAL. HIS BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE HOSPITAL. HIS FATHER-IN-LAW BROUGHT HIM HIS REPLACEMENT DEVICE WHILE HE WAS IN THE EMERGENCY ROOM. HE BEGAN USING THE NEW DEVICE WHILE IN THE EMERGENCY ROOM AND LEFT ONCE HIS BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. HIS NORMAL RANGE IS 70-140 MG/DL. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343283 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR Hospitalization BABY ASPIRIN| ZOLOFT| CPAP MACHINE| HUMALOG| METFORMIN| LISINOPRIL