BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173488 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05164
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS:THE BLACK BOX AND PUMP HISTORIES FOR THE EVENT ON (B)(6) 2011 WERE OVERWRITTEN DUE TO CONTINUED PUMP USE. A REVIEW OF THE CURRENT PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. A REVIEW OF THE CURRENT TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2011, HER BLOOD GLUCOSE (BG) ELEVATED TO OVER 500 MG/DL AND SHE EXPERIENCED NAUSEA AND SHORTNESS OF BREATH. SHE STATED THAT SHE RECEIVED A "LOW CARTRIDGE" WARNING THE NIGHT BEFORE, AND DISCONNECTED FROM THE PUMP AND WENT TO BED. SHE REPORTED THAT SHE INSERTED A NEW CARTRIDGE THE FOLLOWING MORNING AND GAVE CORRECTION BOLUSES THROUGHOUT THE DAY, WITH NO RESOLUTION TO HER ELEVATED BG. THE PATIENT REFUSED TO CORRECT VIA SYRINGE. A REVIEW OF THE PUMP HISTORY INDICATED THAT MULTIPLE AUTO-OFF ALARMS AND ONE EMPTY CARTRIDGE ALARM OCCURRED. THE PRIME HISTORY INDICATED THAT THERE WAS A GAP IN TIME BETWEEN WHEN THE AUTO-OFF ALARMS OCCURRED AND WHEN THE PUMP WAS RE-PRIMED. THE TOTAL DAILY DOSE HISTORY WAS FOUND TO BE CORRECT. THE PATIENT DENIED SITE ISSUES OR LEAKING. THE PATIENT REMOVED THE INFUSION SET WHILE ON THE PHONE WITH (B)(4), AND STATED THAT THE CANNULA WAS BENT. THE PATIENT REPORTEDLY INSERTED A NEW SITE/SET AND DELIVERED A CORRECTION BOLUS. THE PATIENT HAS RESUMED INSULIN PUMP THERAPY, AND THERE HAS BEEN NO FURTHER REPORTED INCIDENT. CUSTOMER SUPPORT CONCLUDED THAT THERE WAS NO PRODUCT DEFECT FOUND. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA AFTER FAILING TO APPROPRIATELY RESPOND TO LOW CARTRIDGE AND AUTO-OFF ALARMS.

    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 56 YR Required Intervention