BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2800061 · Received October 22, 2012

    Report

    Report Number
    2531779-2012-12597
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/04/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX CONTAINS DATES FROM (B)(6) 2014. BLACK BOX AND HISTORIES FOR THE EVENT ON (B)(6) 2012 HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. THERE WAS MOISTURE VISIBLE IN DISPLAY. SHORTLY AFTER POWERING ON A REPLACE BATTERY ALARM OCCURS. UNABLE TO PERFORM STEPS 13, 16-22 AND 31 DUE TO MOISTURE DAMAGE. CRACK OBSERVED IN PUMP CASE NEAR TOP RIGHT CORNER OF DISPLAY. LEAK TEST VERIFIES LEAK AT CRACK IN PUMP CASE. PUMP OPENED AND MOISTURE DAMAGE OBSERVED ON PCB. 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) 2012, THE PATIENT'S MOM/REPORTER CLAIMED THAT THERE WAS AN INADVERTENT INFUSION OF 30.8 UNITS DURING A PRIMED SESSION. AT THE TIME OF CONCERN, THE PATIENT'S BLOOD GLUCOSE WENT FROM 150 MG/DL TO 89 MG/DL WITHIN 5 MINUTES OF THE INFUSION. THE PATIENT'S BLOOD GLUCOSE DID NOT DROPPED BELOW 89 MG/DL BECAUSE THE PATIENT'S FAMILY AND SCHOOL NURSE TOOK IMMEDIATE RESPONSE AFTER THE ISSUE BEGAN. THE PATIENT'S DOCTOR INSTRUCTED THE REPORTER TO HAVE A GLUCAGON SHOT AVAILABLE IN CASE THE PATIENT'S BLOOD GLUCOSE DROPPED. THE PATIENT FELT NAUSEATED AND PALE AT THE TIME OF CONCERN. THE PATIENT WAS REMOVED FROM PUMP TREATMENT UNTIL HIS BLOOD GLUCOSE IS STABILIZED. THE REPORTER WILL COMPLETE THE TROUBLESHOOTING OF THE ANIMAS PUMP AFTER THE PATIENT IS STABILIZED. ANIMAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER BACK TO COMPLETE THE REVIEW OF THE ANIMAS PUMP. A LETTER WAS SENT TO THE REPORTER, REQUESTING A CALLBACK. THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION. THIS COMPLAINT IS BEING REPORTED DUE TO POSSIBLE USE ERROR AND BECAUSE THE PATIENT REQUIRED MEDICAL INTERVENTION AFTER A REPORTED INADVERTENT INFUSION OF 30.8 UNITS VIA THE ANIMAS INSULIN PUMP.

    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 7 YR Required Intervention