BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1931639 · Received December 17, 2010

    Report

    Report Number
    2939301-2010-10827
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    December 10, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 (LFS) ALLEGING HIS ONETOUCH PING METER WOULD NOT POWER ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 8AM. THE CUSTOMER CARE ADVOCATE (CCA) WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN (6-7 UNITS). THE PATIENT CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATION. AN HOUR AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT SYMPTOMS OF "TIGHTENING OF HIS MUSCLE, THIRST AND FREQUENT URINATION." THE PATIENT CONFIRMED HE WAS ABLE TO TEST ON ANOTHER DEVICE AND OBTAINED A BLOOD GLUCOSE RESULT OF "320 MG/DL." AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER AND THE BATTERIES WERE RECENTLY REPLACED. THE CCA TRIED TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. GIVEN THE SHORT TIME BETWEEN THE ONSET OF THE ALLEGED ISSUE AND THE REPORTED SYMPTOMS, IT IS UNLIKELY THE PRODUCT ISSUE CONTRIBUTED TO THE REPORTED SYMPTOMS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3041176

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR