BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METER

    MDR report key: 1873133 · Received October 18, 2010

    Report

    Report Number
    2939301-2010-09154
    Event Type
    Injury
    Date Received
    October 18, 2010
    Report Date
    October 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER UNKNOWN ONETOUCH METER DOES NOT TURN ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT ALLEGED THAT THE ISSUE BEGAN APPROXIMATELY FIVE YEARS AGO (DATE/TIME NOT KNOWN). PRIOR TO THE ALLEGED ISSUE, THE PATIENT INDICATED SHE WAS TESTING TWICE A DAY AND MANAGING HER DIABETES WITH HUMULIN 70/30 INSULIN (30 UNITS IN THE MORNING AND 28 UNITS IN THE EVENING). AFTER THE METER ISSUE OCCURRED, THE PATIENT WAS TESTING (WITH HER SISTER'S ONETOUCH ULTRA METER) ONCE A DAY AND CONTINUED WITH HER USUAL DIABETES REGIMEN. ON ACCOUNT OF HER SISTER'S CHANGE IN REGIMEN AND TESTING FREQUENCY, PATIENT INDICATED SHE STOPPED TESTING WITH HER SISTER'S METER IN (B)(6) 2010 (DATE/TIME NOT KNOWN), BEGAN ESTIMATING HOW MUCH FOOD TO CONSUME, AND AS A RESULT WAS TAKING LESS INSULIN THAN NORMAL (ADJUSTED AMOUNT UNKNOWN). THE PATIENT CORRECTED AND CLARIFIED THAT ON EITHER (B)(6) OR (B)(6) 2010 (TIME UNKNOWN), SHE EXPERIENCED SYMPTOMS OF SHAKING, SWEATING, AND FELT LIKE PASSING OUT; HOWEVER, THE PATIENT INDICATED SHE DID NOT SELF-TREAT HER SYMPTOMS AND REFUSED TO GO TO THE EMERGENCY ROOM (ER) TO SEEK MEDICAL INTERVENTION. THE PATIENT INDICATED THE REPORTED SYMPTOMS CONTINUED ON UNTIL (B)(6) 2010. ON THE MORNING OF (B)(6), THE PATIENT STATED SHE CONSUMED SOME FOOD AND DID NOT TAKE ANY INSULIN; HOWEVER, HER SYMPTOMS DID NOT DIMINISH. AT APPROXIMATELY 1:30 PM, THE PATIENT'S SISTER BROUGHT HER TO THE ER. DURING HER TIME IN THE ER, THE PATIENT CONFIRMED SHE OBTAINED A READING OF "309 MG/DL" WITH THE ER/HOSPITAL'S METER AND CLARIFIED SHE WAS ADMINISTERED AN UNKNOWN MEDICATION THROUGH HER IV. THE PATIENT STATED SHE WAS RELEASED FROM THE ER LATER THAT DAY WHEN HER BLOOD GLUCOSE READING DECLINED TO THE "HIGH 100'S". AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE NOTED THE PATIENT HAD ALREADY DISCARDED THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R