BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1901231 · Received November 17, 2010

    Report

    Report Number
    2939301-2010-10022
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    November 2, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT (B)(4) 2011. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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 510K # 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT WAS ADMITTED WITH ACUTE CORONARY SYNDROME FOR WHICH THE CULPRIT VESSEL WAS STENTED. THE PATIENT HAD ONE EPISODE OF ANGINA DURING THE SIX MONTHS FOLLOW UP THAT WAS RELIEVED WITH 2 NITROGLYCERIN WITH NO FURTHER EPISODES. THERE WAS NO ANGIOGRAM PERFORMED. THE PATIENT HAD A FOLLOW-UP STRESS TEST PRIOR TO HIS 12 MONTH CLINIC VISIT, WHICH WAS NORMAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS PROMPTING AN "ERROR 1" MESSAGE. PER THE ONETOUCH PING OWNER'S BOOKLET, THIS ERROR MESSAGE APPEARS WHEN THERE IS A PROBLEM WITH THE METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2010 AT APPROXIMATELY 10:00AM. PRIOR TO WHEN THE ERROR MESSAGE APPEARED, THE PATIENT CLAIMED SHE HAD LAST TESTED WITH THE SUBJECT METER AT 4:00AM THAT MORNING AND OBTAINED A RESULT IN THE "300 MG/DL" RANGE, WHICH WAS ABOVE HER USUAL GLUCOSE RANGE. THE PATIENT STATED SHE ADMINISTERED A BOLUS DOSE OF INSULIN (AMOUNT NOT RECALLED), ATE BREAKFAST AND THEN WENT TO WORK. AT 8:00AM THAT MORNING, THE PATIENT STATED SHE BEGAN TO FEEL A LITTLE THIRSTY. AT THE ONSET OF THE SYMPTOM, THE PATIENT REPORTED SHE TESTED WITH HER BACKUP METER WHICH SHE KEEPS AT WORK AND OBTAINED A RESULT IN THE "180 MG/DL" RANGE. THE PATIENT CLAIMED SHE DRANK A LOT OF WATER AND ADMINISTERED A CORRECTION BOLUS (AMOUNT NOT RECALLED). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT CONFIRMED THAT SHE FELT SYMPTOMATIC PRIOR TO WHEN THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED 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. 2946899

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR