BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3103387 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06124
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    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: DURING INVESTIGATION, IT WAS OBSERVED THAT THE PUMP¿S BLACK BOX FOR (B)(4) 2013 HAD BEEN OVERWRITTEN. A REVIEW OF THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOWED NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT. THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USER'S PROGRAMMED AMOUNTS. THE PUMP SUCCESSFULLY COMPLETED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. THE COMPLAINT WAS NOT ABLE TO BE DUPLICATED DURING THE INVESTIGATION. THERE WAS NO DEFECT FOUND DURING TESTING. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013 CONTACTED ANIMAS REGARDING AN OUTSTANDING BILL. DURING THE CONVERSATION SHE MENTIONED THAT SHE HAD BEEN IN THE HOSPITAL. THE FOLLOWING SEQUENCE OF EVENTS WAS DESCRIBED BY THE PATIENT: THE PATIENT BECAME HYPOGLYCEMIC FOR UNKNOWN REASONS ON THE EVENING OF (B)(6) 2013 AND WAS UNABLE TO ELEVATE HER BLOOD GLUCOSE (BG) INTO NORMAL LIMITS WITH ORAL CARBOHYDRATES. SHE BECAME NAUSEOUS. HER BG WAS SAID TO HAVE BEEN 60 MG/DL USING FINGER STICK BLOOD AND LATER IT WAS 40 MG/DL FROM A VENOUS BLOOD DRAW IN THE HOSPITAL. THE PATIENT ARRIVED AT THE EMERGENCY ROOM (ER) AROUND 10:00PM ON (B)(6) 2013 AND WAS TREATED WITH IV FLUID AND GLUCOSE UNTIL ABOUT 3:00AM ON (B)(6) 2013. THE E.R. PERSONNEL OBSERVED HER UNTIL AROUND 3:00PM WHEN SHE WAS DISCHARGED. DURING A FOLLOW UP CONTACT, THE PATIENT STATED THAT SHE WONDERS IF THE HYPOGLYCEMIA WAS DUE TO A PUMP MALFUNCTION BECAUSE SHE RECEIVED A REPLACEMENT PUMP AND HAS NOT REPORTED BG EXCURSIONS SINCE THE PUMP WAS REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE POSSIBILITY THAT A MALFUNCTION, DEFECT, OR MISUSE OF THE PUMP CAUSED OR CONTRIBUTED TO THE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203845 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization