BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 1760381 · Received July 19, 2010

    Report

    Report Number
    1823260-2010-04197
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 13, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER STATES PATIENT RECEIVED RESULTS OF 30.9 MMOL/L AND 12.3 MMOL/L WITHIN 10 MINUTES ON THE PERFORMA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    A CUSTOMER'S CAREGIVER REPORTED THE TIME AND DATE DID NOT STAY IN THEIR PXTRA METER. THE CALLER ALSO STATED THAT ON (B)(6) 2010, THE METER DISPLAYED "AN UNKNOWN BG NUMBER", WHICH COULD NOT BE VERIFIED BECAUSE OF THE DATE/TIME ISSUE AND THE CUSTOMER INADEQUATELY SELF-MEDICATED, WHICH RESULTED IN A 4-DAY HOSPITALIZATION. AT THE TIME OF THE MEDICAL INCIDENT, THE CUSTOMER REPORTEDLY EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA AND ALSO LOST CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO A LOCAL HOSPITAL DUE TO HIGH GLUCOSE OVER 880 MG/DL (THE SOURCE OF THE READING IS UNKNOWN), WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA. THE INPATIENT TREATMENT IS UNKNOWN. THE CUSTOMER REPORTEDLY SELF-TREATED WITH NOVOLOG AND LANTUS TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 370153

    Patients

    Seq Age Sex Outcome Treatment
    1