BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3052057 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04037
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. . 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

    FOLLOW-UP #1 (B)(4) 2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO PUMP DATA IN THE BLACK BOX FROM THE TIME OF THE EVENT DUE TO CONTINUED PATIENT USE; THERE WAS NO EVIDENCE OF POWER EVENTS OBSERVED IN THE PUMP BLACK BOX. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THE PUMP WAS POWERED ON AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER INTERRUPTIONS OR ALARMS OCCURRING. THE PUMP WAS OPENED AND NO INTERNAL DAMAGE WAS OBSERVED. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DIM; THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN AND THE DISPLAY RETURNED TO NORMAL.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP ALARMED VERIFY BATTERY TYPE. THE PATIENT WAS NOT PERFORMING ANY FUNCTIONS ON THE PUMP WHEN THIS OCCURRED. THE PATIENT STATED THAT WHEN THIS HAPPENED THEY HAVE TO DISCONNECT AND COMPLETE A REWIND LOAD AND PRIME STEP. THE PATIENT CONFIRMED THAT SHE DID NOT SEE THE O RING AT BATTERY CAP AND THE BATTERY WAS STILL SECURE. THE PATIENT DENIED CRACKS AT THE BATTERY COMPARTMENT AND DENIED MOISTURE IN THE PUMP. THE PATIENT STATED THAT THE PUMP HAS NOT REBOOTED SINCE THIS OCCURRENCE. CUSTOMER SUPPORT (CS) ADVISED THE PATIENT THAT THEY WERE UNABLE TO DETERMINE WHY THE PUMP REBOOTED AND ADVISED TO COME OFF THE PUMP. THE PATIENT STATED THAT THEY HAD A BLOOD GLUCOSE (BG) OF 434 MG/DL WITH MILD NAUSEA AND FEELING TIRED. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE PATIENT STATED THAT IS UNUSUAL AND IS NOT RELATED TO UNKNOWN CARBOHYDRATES. THE PATIENT IS ALSO STATUS POST KIDNEY TRANSPLANT AND ON PERITONEAL DIALYSIS. THE PATIENT DENIED INFECTION AND STEROID USE. THIS REPORT IS BEING MADE DUE TO THE INTERMITTENT POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156716 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR