BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1811794 · Received August 23, 2010

    Report

    Report Number
    2954323-2010-01155
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    August 16, 2010
    Report Date
    November 8, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY HOWEVER, THEY WERE OBTAINED OUTSIDE THE TEN MINUTE TIME FRAME. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE PRODUCT IS RETURNED AND INVESTIGATION IS COMPLETE. NOTE: IT SHOULD BE NOTED THAT THE REPORTED METER DISPLAYS "HI" FOR READINGS OVER 500 MG/DL. IT WAS REPORTEDLY GIVEN TO THE CUSTOMER BREAD AND JAM TO ALLEVIATE HIS SYMPTOMS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. AT THE HOSPITAL, IT WAS FURTHER REPORTED THE DOCTORS WANTED TO ADMIT THE CUSTOMER, BUT HE REPORTEDLY REFUSED. THERE WAS NO REPORT OF MEDICAL DIAGNOSIS OR ANY ADDITIONAL MEDICAL TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(4) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT WAS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AFTER INSTALLING A NEW ICT MODULE ON THE ARCHITECT C8000 ANALYZER, THERE HAVE BEEN OCCURRENCES OF HIGH CHLORIDE RESULTS. A PATIENT GENERATED AN INITIAL RESULT OF 127 MMOL/L BUT UPON REPEAT, THE RESULT WAS 103 MMOL/L. THE INITIAL RESULT WAS FLAGGED AS IT WAS HIGHER THAN PREVIOUS CHLORIDE RESULTS AND DID NOT ALIGN WITH OTHER RESULTS FROM THE SAME SAMPLE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE REPORTED THE CUSTOMER RECEIVED A "HI" DISPLAY MESSAGE ON HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER AND THOUGHT THE METER WAS READING HIGHER THAN HE FELT. THE CUSTOMER'S WIFE ALSO REPORTED THE CUSTOMER ONLY ATE AN APPLE SINCE HE WOKE UP AND WHEN HE REPEATED THE BLOOD GLUCOSE TEST, HE RECEIVED ANOTHER "HI" DISPLAY MESSAGE. THE CUSTOMER REPORTEDLY DECIDED NOT TO EAT ANYTHING AND THEN INJECTED HIMSELF WITH INSULIN BEFORE GOING TO SLEEP. AT SOME POINT THE CUSTOMER'S WIFE REPORTED SHE FOUND THE CUSTOMER UNRESPONSIVE AND "LYING IN WATER". SHE REPORTEDLY DESCRIBED THAT THE CUSTOMER EXPERIENCED A HYPOGLYCEMIC EVENT AND SHE STARTED GIVING HIM GLUCOSE THROUGH HIS MOUTH. THERE WAS NO IMPROVEMENT, AND SOON ENOUGH THE CUSTOMER REPORTEDLY LOST CONSCIOUSNESS. THE CUSTOMER'S WIFE REPORTED SHE TREATED THE CUSTOMER WITH A GLUCAGON SHOT AND CALLED THE AMBULANCE. WHILE AWAITING FOR THE AMBULANCE THE CUSTOMER'S WIFE REPORTED SHE CHECKED THE CUSTOMER'S BLOOD GLUCOSE TWICE AND OBTAINED THE FOLLOWING READINGS: A "HI" DISPLAY MESSAGE AND THEN A READING OF 32 MG/DL. THE INTERVAL BETWEEN READINGS IS UNKNOWN. THE CUSTOMER REPORTEDLY REGAINED CONSCIOUSNESS WHEN THE AMBULANCE ARRIVED. ANOTHER BLOOD GLUCOSE TEST WAS DONE IN THE AMBULANCE WITH A HEALTH CARE PROFESSIONAL DEVICE (UNKNOWN) AND A READING OF 36 MG/DL WAS OBTAINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACH END OF LIFE (EOL) WITH A VOLTAGE OF 2.66 AND CHARGE TIMES OF 33 SECONDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 0984211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other