BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3001349 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02642
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 05/14/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: NO ACTIVITY RELATED TO THE COMPLAINT WAS OBSERVED IN THE PUMP BLACK BOX HISTORY. THE PUMP BLACK BOX SHOWED NO EVIDENCE OF INSULIN REMAINING READINGS ABOVE 200 UNITS. DURING TESTING, THE PUMP REWOUND TO 206 UNITS AND THE INSULIN REMAINING WAS FOUND TO BE CALCULATING CORRECTLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: WHEN HE WAS REWINDING HIS PUMP, IT DID NOT STOP AT THE 206 UNIT AND CONTINUED TO REWIND. PATIENT WAS ABLE TO STOP THE REWIND AT 240-245 UNITS AND THEN LOAD HIS CARTRIDGE AND PRIME. DUE TO PISTON ROD REWINDING TOO FAR THE REMAINING INSULIN DISPLAYED ON PUMP IS INCORRECT AND SHOWING AFTER PRIME IT HAS 201 UNITS. HE IS NOT SURE OF EXACT AMOUNT OF INSULIN IN CARTRIDGE BUT STATES IT IS A LOT LESS THAN 201 UNITS. THERE IS NOT ALLEGATION OF A BLOOD GLUCOSE EXCURSION RELATED TO THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP IS INACCURATELY CALCULATING INSULIN ON BOARD, SHOWING MORE INSULIN AVAILABLE THAN THE PATIENT KNOWS TO BE IN THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105733 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR