BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3834005 · Received May 27, 2014

    Report

    Report Number
    2939301-2014-12572
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2014 AT 10:00 PM, THE PATIENT REPLACED THE REPORTED METER¿S BATTERY. AFTERWARDS HE NOTED THE METER WOULD NOT POWER ON; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. ON (B)(6) 2014 AT 6:00 AM THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING, SWEATING AND DIZZINESS. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR A DRINK; HE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE CORRECT AND THERE HAD BEEN NO MISUSE OF THE PRODUCT. THE PATIENT CONTACTED LIFESCAN CUSTOMER SERVICE AFTERWARDS AND REPORTED THAT THERE WAS A STICKER ON THE BATTERY HE HAD INSERTED INTO THE METER. ONCE THE STICKER WAS REMOVED, THE METER POWERED ON SUCCESSFULLY. THE PATIENT MANAGES HIS DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT¿S TECHNIQUE WAS INCORRECT BY INSTALLING A BATTERY INTO THE METER WITH A STICKER ON IT. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE POWER ISSUE OCCURRED, AND RECEIVED TREATMENT WITH FOOD, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310901 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3596323

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R