BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2278111 · Received October 5, 2011

    Report

    Report Number
    2954323-2011-04694
    Event Type
    Injury
    Date Received
    October 5, 2011
    Date of Event
    September 29, 2011
    Report Date
    December 21, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED, A DHR OF THE METER WAS REQUESTED. THE DEVICE HISTORY REVIEW FOR METER SN (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATES OF MANUFACTURE OF THE TWO METERS IS UNKNOWN. ADDITIONALLY: THE SERIAL NUMBERS OF THE TWO METERS IS ALSO UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HE HAD BEEN GETTING LOW READINGS FROM HIS FREESTYLE FLASH BLOOD GLUCOSE METER, BUT WOULD EXPERIENCE HIGH BLOOD GLUCOSE SYMPTOMS. HE ALSO NOTED RECEIVING HIGH READINGS FROM HIS FS LITE METER, BUT WOULD EXPERIENCE LOW BLOOD GLUCOSE SYMPTOMS. CUSTOMER REPORTED THE FOLLOWING RESULTS: 2.8 MMO/L (50 MG/DL), 1.1 MMO/L (20 MG/DL), 1.6 MMO/L (29 MG/DL), 4.9 MMO/L (88 MG/DL) AND 5.8 MMO/L (105 MG/DL), WHICH WERE LOWER THAN HE FELT. CUSTOMER ADDITIONALLY REPORTED THE FOLLOWING RESULTS: 7.72 MMO/L (139 MG/DL), 6.2 MMO/L (112 MG/DL), 9.8 MMO/L (176 MG/DL), 24.2 MMO/L (436 MG/DL), 6.35 MMO/L (114 MG/DL) AND 8.0 MMO/L (144 MG/DL), WHICH WERE HIGHER THAN HE FELT. THE DATES AND TIMES WHEN THESE RESULTS WERE OBTAINED WAS NOT PROVIDED AS CUSTOMER DID NOT HAVE HIS METERS WITH HIM DUE TO GIVING THEM TO HIS PHARMACIST. IT WAS FURTHER REPORTED CUSTOMER EXPERIENCED VERTIGO, BLURRED VISION, WEAKNESS, POLYDIPSIA, POLYURIA, FELT "DOPED UP", WAS "UNSURE OF THINGS" AND FELT AS IF HE WAS GOING TO FALL TO THE FLOOR. CUSTOMER FURTHER REPORTED HE COMPLAINED ABOUT THE LOW READINGS TO THE PHARMACIST AND WAS INSTRUCTED TO TAKE MORE "SUGAR PILLS" AND THEN EXPERIENCED A LOSS OF CONSCIOUSNESS AND A SEIZURE ON (B)(6) 2011. NO THIRD-PARTY EMERGENT MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER SELF-TREATED BY DRINKING WATER AND TAKING THE SUGAR PILLS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other