BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3122559 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06818
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) 2013, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF THE LAY-USER/PATIENT ALLEGING THE PATIENT REQUIRED MEDICAL INTERVENTION FOR DKA WHILE HE MANAGED HIS DIABETES WITH THE ANIMAS PUMP. THE PATIENT¿S HYPERGLYCEMIC READINGS BEGAN ON (B)(6) 2013 AT 8:37 PM WITH RESULTS OF 304 MG/DL. ACCORDING TO THE REPORTER, THE PATIENT DID NOT TAKE ANY CORRECTION BOLUS AT THE TIME OF CONCERN. ON (B)(6) 2013 AT 4:11 AM, THE ANIMAS PUMP ALERTED THE PATIENT WITH OCCLUSION ALARMS. THE PATIENT REPORTEDLY DID NOT CONFIRMED ALARM UNTIL 6:30 AM. THE PATIENT¿S MOM ACKNOWLEDGED THAT THE PATIENT WAS NOT GETTING ANY BASAL INSULIN FOR AT LEAST TWO HOURS AFTER THE ALARM BEGAN. THE PATIENT¿S BLOOD GLUCOSE READ IN THE 400, 500 MG/DL AND EVENTUALLY HI, ABOVE 600 MG/DL FOR THE REST OF DAY. THE PATIENT TOOK INSULIN VIA SYRINGE AND WAS KEPT ON INSULIN PUMP THERAPY BUT HIS ELEVATED BLOOD GLUCOSE DID NOT SUBSIDE. ON (B)(6) 2013 AT 4 PM, THE PATIENT WAS HOSPITALIZED AND TREATED FOR DKA. HE REMAINED HOSPITALIZED ON (B)(6) 2013 DURING THE PHONE CALL TO ANIMAS. THE PATIENT WAS OFF OF THE INSULIN PUMP AND IS TAKING MANUAL INSULIN DOSAGE. HIS MOST RECENT BLOOD GLUCOSE REPORTEDLY WAS AT 263 MG/DL. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONFIRMED THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE BASAL SETTING WAS CORRECTLY SET. THE TOTAL DAILY DOSE OF INSULIN ADDED UP CORRECTLY. THE PATIENT¿S HYPERGLYCEMIA CAN BE ATTRIBUTED TO USE ERROR SINCE THE PATIENT DID NOT TAKE ANY CORRECTION BOLUS INSULIN AND DID NOT CONFIRM THE OCCLUSION ALARM FOR 2 HOURS. THIS COMPLAINT IS BEING REPORTED DUE TO USE ERROR AND BECAUSE THE PATIENT REQUIRED MEDICAL INTERVENTION FOR DKA WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225042 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| R