BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2902306 · Received January 8, 2013

    Report

    Report Number
    2531779-2013-00390
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT SEVERAL LOW BLOOD GLUCOSE (BG) EXCURSIONS WHILE USING THE SUBJECT PUMP. THE PATIENT REPORTED THAT BEGINNING IN (B)(6) 2010 SHE BEGAN TO HAVE SEIZURES DUE TO A LOW BG. THE PATIENT STATED ON ONE OCCASION, SHE BELIEVES IT MAY HAVE OCCURRED IN (B)(6) 2011, HER BG DROPPED TO 15 MG/DL. THE PATIENT STATED HER BOYFRIEND'S MOTHER TREATED HER WITH GLUCAGON AND THEN CALLED 911. THE PATIENT REPORTED THAT SHE WAS TAKEN TO THE HOSPITAL; HOWEVER, IT IS NOT KNOWN WHAT HER BG LEVEL WAS AT THE TIME OF ARRIVAL OR IF SHE RECEIVED ADDITIONAL TREATMENT DURING THE HOSPITAL VISIT. THE PATIENT MENTIONED SHE CONTINUED USE OF THE PUMP AFTER THAT INCIDENT AND HER HCP ADJUSTED PUMP SETTINGS TO AVOID LOW BGS. THE PATIENT INFORMED CUSTOMER SUPPORT THAT SHE DECIDED TO COME OFF THE PUMP IN (B)(6) 2011 AND HAS STAYED ON INJECTION EVER SINCE. THE PATIENT STATED HER HCP WANTED HER TO RESUME INSULIN PUMP THERAPY IN (B)(6) 2013. AT THE TIME OF TROUBLESHOOTING, CUSTOMER SUPPORT DISCOVERED THAT THE PUMP WAS SET TO THE INCORRECT DATE. IT WAS NOTED THAT THE BATTERY HAD BEEN OUT OF THE PUMP FOR OVER 1 YEAR AND THE TIME AND DATE HAD TO BE RESET. REVIEW OF PUMP HISTORY INDICATED USE OF PUMP IN 2012; HOWEVER, THE PATIENT CONFIRMED THE PUMP WAS NOT IN USE AT THAT TIME. REVIEW OF ALARM HISTORY REVEALED SEVERAL AUTO OFF ALARMS. THE PATIENT CONFIRMED SHE WAS ALWAYS DISCONNECTED WHEN SHE PRIMED THE PUMP. AT THE TIME OF THE CALL, THE PATIENT MENTIONED SHE WAS 3 OR 4 MONTHS POSTPARTUM WHEN SHE BEGAN TO EXPERIENCE THE LOW BG EXCURSIONS. THE PATIENT STATED THAT ONLY HER HCP MADE ADJUSTMENTS TO THE PUMP'S ADVANCED FEATURES. THE PATIENT DID NOT KNOW IF HER HCP EVALUATED AND CHANGED HER I:C RATIO AFTER HAVING HER CHILD DUE TO SIGNIFICANT WEIGHT CHANGE. CUSTOMER SUPPORT NOTED THAT REVIEW OF THE PUMP DID NOT REVEAL ANY MECHANICAL ISSUES RELATED TO THE PATIENT'S ALLEGED LOW BG SEIZURES. ALTHOUGH REVIEW OF THE SUBJECT PUMP DID NOT REVEAL A MALFUNCTION OF THE DEVICE, THIS COMPLAINT IS BEING REPORTED BASED ON THE INFORMATION THAT THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND 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
    9548 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| L| R