BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2963835 · Received February 15, 2013

    Report

    Report Number
    2531779-2013-01844
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED NO ALARMS OR WARNINGS RELATED TO THE EVENT. THE PUMP WAS FOUND TO BE DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. UNRELATED TO THE EVENT CORROSION WAS OBSERVED IN THE BATTERY COMPARTMENT. THE FORCE SENSOR WAS FOUND TO BE READING HIGH FORCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE USERS OF THE PUMP NOTICED THAT THE TIME/DATE WERE INCORRECTLY SET BUT DID NOT CHANGE THE SETTING AS INSTRUCTED IN THE OWNER'S BOOKLET. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE TIME/DATE HAD RESET TO DEFAULT AT SOME UNKNOWN POINT. THE REPORTER CLAIMED THAT THE ISSUE WAS NOT NOTICED DURING BATTERY CHANGES BUT COULD NOT BE CERTAIN. THE TIME/DATE WAS CORRECTLY SET WHEN THE REPORTER CONTACTED ANIMAS FOR A PUMP REPLACEMENT. DURING THIS CONTACT, THE REPORTER MENTIONED THAT ON (B)(6) 2013 THE PATIENT EXPERIENCED HYPOGLYCEMIA WITH SEIZURE FOR WHICH THE REPORTER TREATED THE PATIENT WITH GLUCAGON. SUBSEQUENT BLOOD GLUCOSE (BG) READING PRIOR TO THE ARRIVAL OF EMERGENCY PERSONNEL WAS 47MG/DL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND KEPT OVERNIGHT. ACCORDING TO THE REPORTER, THE PATIENT CONTINUED TO USE THE PUMP WITHOUT FURTHER BG EXCURSIONS UNTIL A REPLACEMENT ARRIVED. THE REPORTER ASSERTED THAT THE LOW BG WAS NOT RELATED TO THE PUMP; IT WAS SAID THAT THE PATIENT ONLY USES THE PUMP FOR BOLUS INSULIN DELIVERY. THE PATIENT'S PHYSICIAN WAS CONTACTED AND SAID THAT THE LOW BG WAS A REBOUND EFFECT TO THE PATIENT'S WINTER ILLNESSES. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP AND THE REPORTER CONFIRMED THAT ALL SETTINGS AND DELIVERIES WERE CORRECT. HOWEVER, IT WAS SAID THAT THERE WERE MULTIPLE BOLUS SETTINGS FOR VARIOUS TIMES OF DAY. ALTHOUGH THE PUMP MAY NOT HAVE CAUSED THE HYPOGLYCEMIA, THE USE OF INCORRECT BOLUS SETTINGS DUE TO THE PUMP'S TIME NOT BEING SET CORRECTLY MAY HAVE CONTRIBUTED TO THE EVENT. FOR THIS REASON, THE COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68381 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization