BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2933263 · Received January 29, 2013

    Report

    Report Number
    1823260-2013-00485
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 30, 2012
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER WAS FEELING WEAK AND SHAKY. CUSTOMER NORMALLY BEGINS TO FEEL LOW BLOOD SYMPTOMS AT 90 MG/DL. CUSTOMER TESTED ON HER AVIVA METER AND RECEIVED A RESULT OF 104 MG/DL AT THIS TIME. CUSTOMER ATTEMPTED TO SELF- TREAT BY EATING A BOWL OF (B)(6). CUSTOMER TOOK ONE BITE BUT FELT TOO BAD TO CONTINUE. CUSTOMER CALLED THE PARAMEDICS WHO ARRIVED 1 HOUR AFTER THE RESULT OF 104 MG/DL. CUSTOMER WAS GIVEN OXYGEN AND AN EKG. THE PARAMEDIC'S METER READ 87 MG/DL. WHILE CUSTOMER WAS EN ROUTE TO THE HOSPITAL, PARAMEDICS TREATED HER WITH AN UNSPECIFIED SUGAR EMULSION. AT THE HOSPITAL, APPROXIMATELY 20 MINUTES LATER, THE PARAMEDIC'S METER READ 81 MG/DL. WHILE IN THE EMERGENCY ROOM THE CUSTOMER OBTAINED AN UNSPECIFIED RESULT FROM HER AVIVA METER AND SELF-TREATED WITH A PIECE OF CANDY. CUSTOMER DID NOT RECEIVE ANY FURTHER TREATMENT AT THE HOSPITAL AND WAS DISCHARGED THAT AFTERNOON. CUSTOMER HAS FULLY RECOVERED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39688 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491384

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female ALBUTEROL| CRESTOR| GABAPENTIN| HYDROCHLOROTHIAZIDE| JANUVIA| LORAZEPAM| MICARDIS| NEXIUM| PRANDIN| PRANDIN| GABAPENTIN| MICARDIS| JANUVIA| LORAZEPAM| HYDROCHLOROTHIAZIDE| NEXIUM| ALBUTEROL| CRESTOR