BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3151330 · Received June 7, 2013

    Report

    Report Number
    2531779-2013-07881
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 08/13/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/18/2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX HISTORY SHOWED THAT A LOW BATTERY WARNING AND TWO REPLACE BATTERY ALARMS. SEVERAL POWER EVENTS WERE OBSERVED ON 05/12/2013. THE PUMP BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND EVIDENCE OF MOISTURE WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE BATTERY CAP WAS INSERTED BUT WAS UNABLE TO TIGHTEN SECURELY TO THE PUMP DUE TO THE DAMAGED BATTERY CAP THREADS. A TEST CAP WAS INSERTED AND THE PUMP POWERED ON AND EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE WAS FOUND INSIDE THE PUMP. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED AND THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 ALLEGING THE PUMP HAD BEEN RANDOMLY POWERING OFF ON ITS OWN WITHOUT USER INTERVENTION FOR THE PAST WEEK. THE PATIENT REPORTED THE VERIFY BATTERY SCREEN APPEARS ON THE PUMP ¿FOR NO REASON¿. THE PATIENT REPORTED THAT THE PUMP POWERED OFF DURING THE PRIOR NIGHT WITHOUT HER KNOWLEDGE WHILE SHE WAS SLEEPING. THE PATIENT STATED THAT HER BLOOD GLUCOSE (BG) ELEVATED TO 498 MG/DL WITHOUT REPORTED SYMPTOM SUGGESTIVE OF HYPERGLYCEMIA. THIS REPORTED ELEVATED BG DOES NOT MEET ANIMAS¿ CRITERIA OF A REPORTABLE ADVERSE EVENT. THE PATIENT REPORTED ADMINISTERING A MANUAL INSULIN INJECTION FOR TREATMENT OF THIS ELEVATED BG. THE PATIENT DENIED TRAUMA TO THE PUMP AND CONFIRMED THE BATTERY CAP WAS SEATED PROPERLY ON THE PUMP. THE PATIENT DENIED CRACKS TO THE PUMP CASING OR MOISTURE IN THE PUMP. THE PATIENT DISCONTINUED INSULIN PUMP THERAPY AND BEGAN ON A BACKUP PLAN FOR INSULIN DELIVERY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED RANDOM LOSS OF POWER WITHOUT A KNOWN CAUSE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253336 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR