BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2538578 · Received April 17, 2012

    Report

    Report Number
    2939301-2012-03745
    Event Type
    Injury
    Date Received
    April 17, 2012
    Report Date
    April 5, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING A PRODUCT USABILITY ISSUE WITH HER ONETOUCH PING METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT AT AN UNSPECIFIED DATE AND TIME AT THE (B)(6) 2012, SHE NOTICED THAT THE "FONT ON THE DISPLAY WAS TOO SMALL SEE". THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH THE INSULIN PUMP AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT CLAIMED THAT BECAUSE OF DIFFICULTIES IN SEEING WHAT WAS ON THE DISPLAY DUE TO THE ALLEGED ISSUE, SHE "ADMINISTERED THE WRONG AMOUNT OF INSULIN CAUSING HER TO HAVE AN INSULIN REACTION" AND HALF AN HOUR LATER, SHE "PASSED OUT". THE CCA WAS INFORMED BY THE PATIENT THAT SHORTLY AFTER, SHE WAS ADMINISTERED WITH A "GLUCAGON INJECTION" BY HER HUSBAND IN RESPONSE TO THE SYMPTOMS. THE CCA NOTED THAT THE REPORTED ISSUE REMAINS UNRESOLVED WITH TROUBLE SHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES AFTER THE ALLEGED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R