BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1866220 · Received October 13, 2010

    Report

    Report Number
    2939301-2010-08993
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 28, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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. 510K # K082590.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON BEHALF OF THE LAY-USER/PATIENT ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH PING METER IS GIVING AN ERROR 2 MESSAGE. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. THE ALLEGED ERROR 2 ISSUE BEGAN ON (B)(6) 2010. THE PATIENT TOOK HER USUAL INSULIN AFTER THE ERROR 2 BEGAN. REPORTEDLY, THE NEXT DAY, SHE HAD "HIGH BLOOD GLUCOSE" (UNSPECIFIED NUMERIC VALUES) AND THE PRESENCE OF KETONES IN HER SYSTEM. THERE WAS NO ALLEGATION OF MEDICAL INTERVENTION FOR SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA AT THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE ERROR 2 ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA ONE DAY AFTER THE ERROR 2 BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3034784

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening