BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2183431 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06587
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    July 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    THE LAY REPORTER/ HUSBAND CONTACTED LFS ON (B)(6) 2011 ALLEGING HIGH READINGS ON HIS WIFE'S ONE TOUCH PING METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. APPROXIMATELY 2 WEEKS AGO, THE REPORTER MENTIONED THAT HIS WIFE HAD AN "INSULIN REACTION" AND FELT CONFUSED AND DISORIENTED AND WHEN HE WENT TO TEST HER BLOOD GLUCOSE 10 MINUTES LATER, HER READING WAS 150 OR 175 MG/DL. HE THEN TESTED HER 4 MINUTES LATER ON HER ONE TOUCH ULTRASMART METER AND RECEIVED A SIMILAR READING AS HER ONE TOUCH PING METER. HE THEN TREATED HER WITH JUICE, CRACKERS, AND A GLUCAGON SHOT. HE THEN TESTED HER AGAIN AFTER TREATMENT AND SHE FELT A LITTLE BETTER AND THE READINGS SHE HAD OBTAINED REFLECTED TO HOW SHE WAS FEELING. A QUALITY CONTROL TEST WAS DONE AND THE TEST STRIPS PASSED USING THE CONTROL SOLUTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW READINGS PRIOR TO THE SYMPTOMS, AND HOW MUCH INSULIN WAS GIVEN TO THE PATIENT BASED AND HOW SOON AFTER SHE HAD DEVELOPED THE SYMPTOMS. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE ALLEGED INACCURATE READING, SHE HAD TAKEN INSULIN AND AT AN UNSPECIFIED TIME LATER HAD AN "INSULIN REACTION" AND HER HUSBAND HAD TO TREAT HER WITH JUICE, CRACKERS, AND A GLUCAGON SHOT FOR A BLOOD GLUCOSE READING OF 150-175 MG/DL AND FELT BETTER AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3068815

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening