BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2854636 · Received December 3, 2012

    Report

    Report Number
    2531779-2012-14158
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 23, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT AGAIN CONTACTED ANIMAS ON (B)(6) 2012 REPORTING BLOOD GLUCOSE LEVELS BETWEEN 1.4 MMOL/L AND 19.9 MMOL/L; THE PATIENT INDICATED THAT A HEALTH CARE PROFESSIONAL (HCP) RECOMMENDED DISCONTINUING THE PUMP AS IT MAY BE CONTRIBUTING TO FLUCTUATIONS IN BLOOD GLUCOSE. THE PATIENT STATED THAT THE HCP FELT THAT THE PUMP WAS NOT WORKING AS IT SHOULD. THE PATIENT REPORTED THAT PRIOR TO INSULIN PUMP THERAPY, BLOOD GLUCOSE LEVELS WERE TIGHTLY CONTROLLED BUT ON THE PUMP BLOOD GLUCOSE LEVELS COULD NOT BE MAINTAINED. THE PUMP WAS REVIEWED AND THE PATIENT CONFIRMED THAT THE PUMP SETTINGS WERE CORRECT. THE PUMP HISTORY WAS REVIEWED AND FOUND THAT BASAL AND BOLUS TOTALS CORRECTLY ADDED UP IN THE TOTAL DAILY DOSE HISTORY. THE PATIENT CONFIRMED THAT THERE WERE NO CHANGES IN HEALTH, MEDICATION, ACTIVITY, OR DIET. THE FOLLOWING FIELDS WERE UPDATED BASED ON ADDITIONAL INFORMATION FROM THE PATIENT. THE FOLLOWING WERE INADVERTENTLY OMITTED ON THE INITIAL REPORT. DEVICE: ONETOUCHPING GLUCOSEMGMTSYSTEM; ONETOUCH PING INSULIN PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 DATE OF SUBMISSION 03/27/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/04/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT OBSERVED IN THE PUMP HISTORIES. THE HISTORY SHOWS THE LAST BASAL DELIVERY WAS ON (B)(6) 2012 AT 10:18 AND THE LAST BOLUS WAS ON (B)(6) 2012 AT 23:12. THE PUMP WAS LAST PRIMED ON (B)(6) 2012 AT 07:15. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING BLOOD GLUCOSE LEVELS DOWN TO 1.4 MMOL/L AND WAS ASYMPTOMATIC AT THE TIME. THE PATIENT INDICATED THAT BLOOD GLUCOSE LEVELS WERE POOR SINCE BEGINNING ON THE PUMP A FEW MONTHS EARLIER. THE PATIENT INDICATED THAT THE HEALTH CARE PROFESSIONAL WANTED TO PUT THE PATIENT BACK ON INJECTIONS HOWEVER, THE PATIENT WAS RESISTANT TO RETURN TO INJECTIONS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA OF UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening