BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2042571 · Received April 6, 2011

    Report

    Report Number
    1823260-2011-01920
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT THEY ATTEMPTED TO TEST THE CUSTOMER SEVERAL TIMES ON THE AVIVA SYSTEM WITH STRIPS THAT HAD BEEN LEFT UNCAPPED. REPORTER STATED THAT THEY OBTAINED AN ERROR EACH TIME THEY ATTEMPTED TO TEST OVER A FEW DAYS AND THEY DID NOT GIVE THE CUSTOMER INSULIN ON THE SECOND DAY. THE ERROR WAS AN ERROR WITHIN SPECIFICATION. REPORTER STATED THAT ON SECOND DAY, THE CUSTOMER WAS TIRED AND SHAKY AS IF HE WERE HYPOGLYCEMIC SEVERAL HOURS AFTER THE ERROR MESSAGE WAS OBTAINED. THEY TREATED THE CUSTOMER WITH GLUCERNA IN HIS TUBE FEEDING BAG. REPORTER STATED THAT THE CUSTOMER AWOKE WITH THE SAME SYMPTOMS THE NEXT DAY, THEY GOT ANOTHER ERROR, THE CUSTOMER HAD A SEIZURE AND THE PARAMEDICS WERE CALLED. REPORTER STATED THAT THE CUSTOMER WAS ADMITTED TO THE HOSPITAL WHERE A RESULT OF 600 MG/DL WAS OBTAINED ON THE HOSPITAL SYSTEM AND THE CUSTOMER WAS TREATED WITH 10 UNITS OF HUMULIN R INSULIN. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR Hospitalization| R VITA DROPS| PACEMAKER| SERTRALINE| GLUCERNA| "SHERWOOD KANGAROO PUMP SET"| IPRATROPIUM BROMIDE| FERROUS SULFATE| RANITIDINE| PLAVIX| LANTUS| HUMULIN R| CREON| METOCLOPRAMIDE| SIMVASTATIN| LORATIDINE| ATENOLOL| TRACHEA| PHENYTOIN| ROBUTUSSIN DM