BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2972163 · Received February 21, 2013

    Report

    Report Number
    2531779-2013-01995
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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. USE ERROR CANNOT BE DISCOUNTED AS A CONTRIBUTING FACTOR AS THE PATIENT TOOK TWO BOLUSES 30 MINUTES APART

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 9/12/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2016 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. ACCORDING TO THE PUMP HISTORY THE PUMP WAS RUNNING ON INCORRECT YEAR OF 2007. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER, THE PATIENT'S DAUGHTER, CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: THE PATIENT WAS FOUND UNRESPONSIVE THIS EVENING WITH BLOOD GLUCOSE (BG) OF 14 MG/DL. THE PATIENT IS CURRENTLY UNRESPONSIVE AND GOING FOR A CT SCAN; DAUGHTER HAS PUMP IN HAND AND CAN START THE TROUBLESHOOTING, BUT HAS ONLY SETTINGS FROM 2006 WRITTEN ON A CARD. THE HEALTH CARE PROVIDER (HCP) SUGGESTED THEY CALL ANIMAS TO SEE IF ANYTHING CAN BE FOUND TO BE WRONG WITH PUMP TO EXPLAIN LOW BG. CTS INSTRUCTED DAUGHTER WE WILL NEED TO VERIFY SETTINGS WITH PATIENT AND SPEAK WITH HIM PRIOR TO HIS RESTARTING ON PUMP, GAVE DAUGHTER CONTACT INFORMATION. DAUGHTER REPORTS PATIENT TOOK BOLUS FOR BG LEVEL OF 159 MG/DL PRIOR TO LUNCH AND THEN BOLUSED FOR CARBOHYDRATES HE WAS EATING FOR LUNCH; IT WAS AFTER THAT TIME THAT HE WAS THEN FOUND UNRESPONSIVE. CTS REVIEWED PUMP: LAST ALARM IN HISTORY IS FOR LOW CARTRIDGE FROM (B)(6) 2013 AT 1:05 AM; BOLUS HISTORY SHOWS THE TWO BOLUSES FOR TODAY (B)(6) 2013 OF 2.95 UNITS AT 12:45 PM AND 1.3 UNITS AT 12:14 PM; WIFE HAD VERIFIED THAT PATIENT DID IN FACT TAKE BOLUS FOR BG PRIOR TO TAKING BOLUS FOR CARBOHYDRATE INTAKE AT LUNCH TODAY; NO OTHER BOLUSES FOR TODAY. TOTALS ADD UP. NO ALARMS IN HISTORY, NO PRIME FOR TODAY; NONE SINCE (B)(6) 2013, NO EXTRA BOLUSES, JUST THE TWO TAKEN 30 MINUTES APART. THERE IS NO INDICATION OF PUMP MALFUNCTION. USE ERROR CANNOT BE DISCOUNTED AS A CONTRIBUTING FACTOR. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPOGLYCEMIA AND WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75875 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization