BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1678842 · Received May 5, 2010

    Report

    Report Number
    2939301-2010-03492
    Event Type
    Injury
    Date Received
    May 5, 2010
    Report Date
    April 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE LAY-USER / PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRAMINI METER READ INACCURATELY HIGH. THE PATIENT TESTS HIS BLOOD GLUCOSE 7 TIMES A DAY. HE MANAGES HIS DIABETES WITH HUMALOG INSULIN VIA AN INSULIN PUMP. THE PATIENT TAKES SLIDING-SCALE DOSES OF THE INSULIN BASED ON HIS METER READINGS. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON (B) (6) 2010, AT AN UNSPECIFIED TIME DURING THE MORNING. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "162, 108, 56, AND 162 MG/DL". ABOUT 14 HOURS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS OF FEELING FAINT AND SWEATY. THE PATIENT WAS UNABLE TO RECALL WHAT SPECIFIC METER READINGS HE OBTAINED PRIOR TO DEVELOPING THE SYMPTOMS. HE ALSO WAS NOT SURE IF HE TOOK ANY INSULIN PRIOR TO DEVELOPING THE SYMPTOMS. HE REMEMBERED EATING BREAKFAST AND LUNCH AS USUAL THAT DAY. WHILE FEELING LOW, THE PATIENT'S WIFE REPORTEDLY TESTED HIS BLOOD GLUCOSE WITH THE REPORTED METER AND GOT "167 MG/DL". PARAMEDICS WERE CONTACTED. WHEN THEY ARRIVED, THE PARAMEDICS TESTED THE PATIENT WITH AN EMERGENCY MEDICAL SERVICES (EMS) METER AND A RESULT OF "37 MG/DL" WAS OBTAINED. THE PATIENT STATED THAT HE WAS TAKEN TO A HOSPITAL WHERE HE RECEIVED UNKNOWN TREATMENT TO RAISE HIS BLOOD GLUCOSE. HE WAS RELEASED FROM THE HOSPITAL AFTER A FEW HOURS. THE METER AND TEST STRIPS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2953659

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Life Threatening| H| R