BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2882185 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14935
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. ONLY TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED IN THE ALARM HISTORY; THERE WERE NO ALARMS RELATED TO THE COMPLAINT RECORDED. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE SUBJECT PUMP WAS FAULTY. THE PATIENT REPORTED THAT ON THE MORNING OF (B)(6) 2012 SHE OBTAINED A BLOOD GLUCOSE (BG) READING OF "360 MG/DL" WITH HER ONETOUCH PING METER. THE PATIENT STATED SHE HAVE HERSELF A CORRECTION DOSE OF INSULIN IN RESPONSE TO THE BG RESULT. IT IS NOT KNOWN WHAT SYMPTOMS THE PATIENT DEVELOPED AFTER ADMINISTERING THE CORRECTION DOSE, BUT SHE STATED HER SUGAR WENT EXTREMELY LOW AND EMS WAS CONTACTED. THE PATIENT REPORTED SHE WAS TREATED AT HOME BY EMS WITH "IV FLUIDS AND DEXTROSE" AND DECLINED TO BE TAKEN TO THE HOSPITAL FOR FURTHER EVALUATION. AT THE TIME OF THE CALL, THE PATIENT INFORMED CUSTOMER SUPPORT THAT SHE HAD RECEIVED A READING "UNDER 50 MG/DL" WITH HER DEXCOM CONTINUOUS MONITORING SYSTEM; HOWEVER, IT IS NOT KNOW IF THAT RESULT WAS OBTAINED PRIOR TO OR AFTER ADMINISTERING THE CORRECTION BOLUS. THE PATIENT INFORMED CUSTOMER SUPPORT THAT SHE WAS ADVISED BY HER HCP TO CALL IN FOR PUMP REPLACEMENT. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THE PUMP WAS SET TO THE CORRECT DATE AND TIME. CUSTOMER SUPPORT NOTED THAT THE PATIENT DID NOT USE THE PUMP'S ADVANCED FEATURES. IT WAS NOTED THAT THE PATIENT WAS ABLE TO PRIME AND BOLUS PUMP WITHOUT EXTRA INSULIN INFUSING. CUSTOMER SUPPORT NOTED THAT THE PUMP WAS DELIVERING CORRECT AMOUNT OF INSULIN PER PROGRAM. CUSTOMER SUPPORT EXPLAINED TO THE PATIENT THAT THE PUMP WAS FUNCTIONING. THE PUMP WAS REPLACED FOR THE PATIENT'S COMFORT AND HCP'S REQUEST. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS REPORTEDLY TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP WHILE ON INSULIN PUMP THERAPY. ALTHOUGH REVIEW OF THE PUMP DID NOT REVEAL A MALFUNCTION OF THE DEVICE, INSULIN PUMP USE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    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 56 YR Life Threatening| R