BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1030032 · Received April 14, 2008

    Report

    Report Number
    2939301-2008-00568
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA METER HAS A POWER ISSUE (METER DOES NOT TURN ON). THIS MEDICAL SPECIALIST CONTACTED THE PT TO OBTAIN MORE INFO NINE DAYS LATER. AFTER THE REPORTED ISSUE BEGAN NINE DAYS PRIOR, AT 6PM (EST), THE PT WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING AND DID NOT KNOW WHAT HIS BLOOD GLUCOSE WAS AT THE TIME OF CONCERN. THE PT WAS FEELING FINE (WITHOUT SYMPTOM) WHEN HE WOKE UP AT 6AM. THE PT TOOK 3 UNITS OF HUMALOG BEFORE HE ATE BREAKFAST BASED ON THE WAY HE WAS FEELING AND HIS FOOD INTAKE. AT A LATER TIME, THE PT DEVELOPED SYMPTOMS OF "DIZZY, COLD SWEAT, AND WEAK." AFTER THE PT DRANK SOME COFFEE WITH SUGAR AND REPORTEDLY FELT BETTER, HE TESTED ON THE BACKUP METER IN THE "LOW 80S MG/DL". THE PT STATED THAT HE MAY HAVE BEEN ABLE TO PREVENT THE SYMPTOMS IF HE KNEW WHAT HIS BLOOD GLUCOSE WAS THAT MORNING. IN ADDITION, THE PT INDICATED THAT HE WOULD HAVE EATEN MORE SUGAR AND/OR TOOK LESS INSULIN IF HE HAD KNOW WHAT HIS BLOOD GLUCOSE WAS. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS NOT RESOLVED. ALTHOUGH THERE IS NO EVIDENCE OF PROD MISUSE AND THE BATTERY WAS REPLACED PER THE OWNER'S MANUAL, THE LFS METER DID NOT TURN WITH THE POWER BUTTON PRESSED AND THE TEST STRIP INSERTED INTO THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODS WERE SENT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention