BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1913168 · Received December 2, 2010

    Report

    Report Number
    2939301-2010-10453
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH PING 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) 2010, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT CLAIMED THAT FOR A FEW WEEKS PRIOR, THE REPORTED METER WOULD POWER OFF DURING USE. DURING THIS TIME, THE PATIENT TOOK THE ACTION OF CONSUMING LESS FOOD. THE PATIENT MANAGES HER DIABETES WITH INSULIN U-500 USING A PUMP. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF NAUSEA AND VOMITING, AND VISITED HER PHYSICIAN. THE PATIENT WAS SENT TO THE EMERGENCY ROOM, WHERE HER BLOOD GLUCOSE LEVEL WAS TESTED TO BE 412 MG/DL. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND WAS TREATED WITH INTRAVENOUS INSULIN AND FLUIDS, AND ANTIBIOTICS. TROUBLESHOOTING REVEALED THE PATIENT HAD CORRECTLY REPLACED THE METER'S BATTERY, THE TEST STRIPS WERE CORRECT AND THERE HAD BEEN NO MISUSE OF THE METER. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO THE REPORTED METER, AND RECEIVED EMERGENCY TREATMENT WITH INSULIN AND FLUIDS AND HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3009837

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| L