BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3031141 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03445
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S BLACK BOX HISTORY WAS REVIEWED AND SHOWED THE PUMP HAD REBOOTED. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT; NO STRIPPED THREADS WERE OBSERVED. THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP WAS OBSERVED TO HAVE STRIPPED THREADS. THE RETURNED BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION TO THE PUMP; POWER LOSS WAS DUPLICATED WITH THE RETURNED BATTERY CAP. A NEW TEST BATTERY CAP WAS ABLE TO FULLY SECURE TO THE PUMP WITH NO VISIBLE YELLOW O RING. A 1 UNIT PER HOUR BASAL PROGRAM WAS EXECUTED IN THE PUMP FOR A 24 HOUR DURATION PERIOD USING A TEST BATTERY CAP; NO POWER INTERRUPTIONS WERE DUPLICATED. REMOVAL OF THE PUMP COVER SHOWED NO EVIDENCE OF INTERNAL MOISTURE. NO DAMAGE TO THE POWER CIRCUIT WAS OBSERVED. 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT AND HIS WIFE CALLED ANIMAS AND ALLEGED THE FOLLOWING: PATIENT IS HAVING BLOOD GLUCOSE (BG) IN THE 250 MG/DL RANGE RELATED TO PUMP REBOOTING. PATIENT IS HAVING AN ISSUE WITH THE PUMP REBOOTING UNINTENTIONALLY, STATED THAT HE CHANGED THE BATTERY CAP ABOUT A MONTH IN A HALF AGO BUT PRIOR TO THAT, HE ONLY CHANGED THE BATTERY CAP ABOUT EVERY YEAR OR SO, ABOUT 3 TIMES SINCE HE RECEIVED THIS PUMP IN 2011. THE PUMP IS STILL REBOOTING UNINTENTIONALLY, AT TIMES IN THE MIDDLE OF THE NIGHT AND WHILE AT WORK WHEN HE DOESN'T HEAR THE SOUNDS WHEN IT COMES BACK ON AND IS WITHOUT INSULIN AND HIS BG GETS ELEVATED. PATIENT STATED THAT THE THREADS ARE GOOD ON THE BATTERY CAP BUT THE THREADS ON THE INSIDE OF THE BATTERY COMPARTMENT ARE STRIPPED AND COMPLETELY WORN OUT. DENIES ANY CRACKS IN THE PUMP. THE REBOOTING HAS HAPPENED TWICE TODAY AND STATED THAT IT HAPPENS AT LEAST 3-4 TIMES A DAY. PATIENT STATED THAT HE REPLACES THE BATTERY CAP, REWINDS THE PUMP, LOADS AND PRIMES AND GIVES A CORRECTION BOLUS AND BG RETURNS TO TARGET EASILY. STATED THAT HE HAS WOKEN UP IN THE MIDDLE OF THE NIGHT AND BG WAS AS HIGH AS 250 MG/DL, STATED THAT HE FEELS REALLY SLEEPY WHEN BG IS AT 250 MG/DL. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED PATIENT TO COME OFF THE PUMP UNTIL A REPLACEMENT IS RECEIVED AND GO TO ALTERNATE FORM OF INSULIN DELIVERY: STATED THAT HE DOES HAVE AN ALTERNATE FORM OF INSULIN DELIVERY BUT THAT HE IS GOING TO CONTINUE TO USE THE PUMP. CTS EXPLAINED THE RISK OF USING THE PUMP AGAINST MEDICAL ADVICE: POWER INTERRUPTIONS AND CONSEQUENT HIGH BG, VERBALIZES UNDERSTANDING. THE BLOOD GLUCOSE EXCURSION DOES NOT MEET THE CRITERIA OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT KNOWINGLY USED A DEVICE WITH A DAMAGED COMPONENT THAT AFFECTED THE FUNCTIONALITY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133543 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR