BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1930891 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10806
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/20/2010. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE CRACKED/BROKEN DISPLAY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K082590. 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. PRODUCTS WERE REPLACED AND REQUESTED BACK. METER WAS RETURNED WITH THE FOLLOWING FINDINGS: THE LCD WAS CRACKED/ BROKEN ON THE METER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS BEING REVISED DUE TO A FRACTURED ALUMINA INSERT.

    Description of Event or Problem · 1

    THE LAY REPORTER / MOTHER CONTACTED LFS ON (B)(6) 2010 ALLEGING A LINE THROUGH THE DISPLAY ON HER DAUGHTER'S ONE TOUCH PING METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE REPORTER AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION: THE REPORTER MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN ON (B)(6) 2010 AT AROUND 4:00PM. DUE TO THE REPORTED ISSUE THE PATIENT CONTINUED TO TAKE HER USUAL DOSAGE OF DIABETES MEDICATION. APPROXIMATELY 2 DAYS LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING LETHARGIC AND HAD AN UPSET STOMACH. THE MOTHER TESTED THE PATIENT ON A BACK UP METER AND OBTAINED A 492 MG/DL AND TREATED HER WITH INSULIN. THE REPORTER DENIED ANY MISUSE OF THE PRODUCT. THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE METER WAS REPLACED. IT IS UNKNOWN WHETHER THE PATIENT WAS STILL ABLE TO OBTAIN AND SEE THE NUMERICAL VALUES ON THE METER, IT IS ALSO UNKNOWN WHETHER THE PATIENT TESTED ON THE BACK UP METER DUE TO THE ALLEGED ISSUE AND BEFORE DEVELOPING SYMPTOMS. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT THE PATIENT WAS UNABLE TO TEST DUE TO A LINE THROUGH THE DISPLAY, DEVELOPED SYMPTOMS 2 DAYS LATER AND HAD TO TREATED HER WITH INSULIN FOR A BLOOD GLUCOSE OF 492 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3067053

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Life Threatening