BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232858 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06435
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A REVIEW OF THE PUMP HISTORY INDICATED A "REPLACE BATTERY" ALARM OCCURRED ON (B)(6) 2011 AT 7:22 AM, AND A PARTIALLY DISCHARGED BATTERY WAS INSERTED. MULTIPLE "REPLACE BATTERY" ALARMS WERE OBSERVED IN THE ALARM HISTORY ON (B)(6) 2011. THE ROOT CAUSE OF THESE ALARMS COULD NOT BE ADEQUATELY INVESTIGATED DUE TO THE BLACK BOX HISTORY BEING OVERWRITTEN FROM CONTINUED PUMP USE. EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. THE PUMP WAS EXERCISED FOR THREE HOURS WITH NO EVIDENCE OF OVERHEATING. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. VISUAL INSPECTION REVEALED CORROSION INSIDE THE BATTERY COMPARTMENT. CORROSION IN THE BATTERY COMPARTMENT IS NOT LIKELY TO CAUSE AN ADVERSE EVENT, AS THE ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE BATTERY WAS HOT TO THE TOUCH WHEN PERFORMING A ROUTINE BATTERY CHANGE. HE STATED THAT THERE WAS NO INJURY SUSTAINED AS A RESULT OF THE ISSUE. THE FAMILY MEMBER DENIED PHYSICAL DAMAGE TO THE BATTERY CAP AND COMPARTMENT, AND CONFIRMED THAT THE BATTERY CAP WAS SECURE TO THE PUMP. HE STATED THAT THE BATTERY CAP WAS NEVER CHANGED; HE ADMITTED THAT THE PUMP IS EXPOSED TO WATER FREQUENTLY WHEN THE PATIENT SWIMS. THE USER GUIDE ADVISES THE USER TO CHANGE THE BATTERY CAP EVERY THREE MONTHS IF THE PUMP IS EXPOSED TO WATER OR DUST.

    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 11 YR