BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2974812 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02068
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 05/17/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP'S HISTORY AND BLACK BOX WERE REVIEWED AND SHOWED THAT THE LAST BASAL DELIVERY AND BOLUS WERE ON (B)(6) 2013. REVIEWS OF THE TOTAL DAILY INSULIN TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATE. THE ALARM HISTORY AND THE BLACK BOX SHOWED NO ERRORS OR ALARMS RELATED TO THE COMPLAINT; ONLY TYPICAL USAGE WAS OBSERVED. THE PUMP SUCCESSFULLY COMPLETED AND PASSED THE REQUIRED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATIONS. A FORCE SENSOR CALIBRATION WAS FOUND NOT TO BE WITHIN SPECIFICATIONS. THE FORCE SENSOR RESISTANCE WAS WITHIN SPECIFICATIONS. THERE WERE NO INSULIN DELIVERY DEFECTS FOUND DURING INVESTIGATION.

    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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 BECAUSE SHE WAS CONFUSED WITH BATTERY REPLACEMENT. AT THAT TIME SHE MENTIONED THAT HER BLOOD GLUCOSE (BG) DROPPED TO 29 MG/DL WITH SHAKINESS, SWEATINESS, POUNDING HEART AND FELT A LITTLE OUT OF IT IN THE MIDDLE OF THE NIGHT. SHE TREATED WITH CARBOHYDRATES AND BG ROSE TO 86 MG/DL. THE PATIENT STATED SHE HAD A HISTORY OF HYPOGLYCEMIA OCCURRING IN THE MIDDLE OF THE NIGHT AS WELL AS DURING THE DAY. HER HEALTHCARE PROFESSIONAL THOUGHT THAT THE PUMP MAY HELP CONTROL HER BG. THE PATIENT CHANGED BATTERY AND CARTRIDGE/SITE/SET. CUSTOMER SUPPORT COMPLETED TROUBLESHOOTING AND BASAL SETTINGS WERE CONFIRMED TO BE CORRECT. ALL PUMP SETTINGS WERE FOUND TO BE CORRECT. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S HYPOGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78373 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening