BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1012656 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00318
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 28, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE HAS EXPERIENCED REPEATED OCCLUSION (04) ERRORS ON HER INFUSION DEVICE AND HER BLOOD GLUCOSE HAS BEEN ELEVATED (400 MG/DL). HER NORMAL BLOOD GLUCOSE LEVEL IS 300 MG/DL. SHE STATED THAT SHE PRIMES THE INFUSION TUBING WITHOUT ERROR UNTIL INSULIN DRIPS FROM THE END, AND SHE THEN CHANGES HER INFUSION SITE. SHE STATED THAT WITHIN A FEW HRS AFTER INSERTING THE NEW SITE, THE INFUSION DEVICE BEGINS TO OCCLUDE AGAIN. SHE STATED THAT SHE DOES HAVE SCAR TISSUE ON HER ABDOMEN. THE PT DID NOT HAVE HER INFUSION DEVICE OR SUPPLIES TO TROUBLESHOOT. SHE REPORTED THAT SHE WAS ADMITTED TO THE HOSPITAL THREE DAYS EARLIER DUE TO ELEVATED BLOOD GLUCOSE. SHE WAS CURRENTLY ON INJECTION THERAPY AND STATED THAT HER BLOOD GLUCOSE REMAINED ELEVATED ("HI" OVER 500 MG/DL). UPON FOLLOW UP ON THE DAY PRIOR TO ORIGINAL DATE, THE PT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND TO REMOVE THE INSULIN CARTRIDGE AND TO PERFORM AN EMPTY PRIME. SHE WAS ABLE TO DO SO WITHOUT ERROR. SHE WAS THEN INSTRUCTED TO INSERT A NEW INSULIN CARTRIDGE AND ADAPTER AND SHE WAS ABLE TO PRIME THROUGH THE ADAPTER WITHOUT ERROR. SHE WAS THEN ABLE TO ATTACH AN INFUSION TUBING AND PRIME WITHOUT ERROR. SHE RECONNECTED TO HER INFUSION SITE AND BOLUSED. FURTHER ATTEMPTS TO FOLLOW UP WITH THE PT WERE UNSUCCESSFUL. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRONPLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R INSULIN INFUSION SET| INSULIN