BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-GO (H-PATCH) 20 UNIT BASAL / VALERITA

    MDR report key: 1032045 · Received April 18, 2008

    Report

    Report Number
    1226572-2008-00001
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 2, 2008
    Manufacturer
    VALERITAS, LLC
    Product Code
    LZG
    PMA / PMN Number
    K050971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CONTINUED USING THE DEVICE IN ACCORDANCE WITH HER PHYSICIAN'S DIRECTION AND DID NOT RETURN IT TO VALERITAS, HOWEVER, THE FACTS OF THE EVENT INDICATED THAT THE DEVICE WAS FUNCTIONING PROPERLY AND THAT PHYSICAL EVAL OF THE DEVICE (OR RELATED DEVICES FROM THE SAME LOT) WAS NOT REQUIRED. THE EVENT WAS DISCOVERED DURING A REGULARLY SCHEDULED FOLLOW-UP PHONE CALL BY A VALERITAS REP TO THE PT, IN WHICH THE PT INDICATED THAT 3 SUCCESSIVE BLOOD GLUCOSE READINGS WERE LOW. THE VALERITAS REP NOTIFIED THE PT'S PHYSICIAN WHO IN TURN CONTACTED THE PT AND ADVISED THAT SHE CONTINUE USING THE V-GO DEVICE, BUT TO REDUCE THE BOLUS DOSE TAKEN WITH EACH MEAL. THIS INTERVENTION RESULTED IN THE PT'S BLOOD GLUCOSE LEVELS RETURNING TO NORMAL.

    Description of Event or Problem · 1

    (B) (6) HAS TYPE DIABETES SINCE (B) (6) WITH YRS OF INSULIN THERAPY, MOST RECENTLY PRESCRIBED LANTUS 30 UNITS QHS AND HUMALOG 12-14 UNITS WITH EACH MEAL. PT STARTED V-GO THERAPY, WITH V-GO FILLED WITH APIDRA (GLULISINE). BASAL RATE SELECTED WAS 20 UNITS OVER 24 HRS; PHYSICIAN INSTRUCTED PT TO ADMINISTER 12 UNITS OF INSULIN WITH EACH MEAL. THERAPY INITIATION ON (B) (6) 2008. DURING A PRESCHEDULED CUSTOMER SVC FOLLOW UP ON (B) (6) 2008, PT VOLUNTEERED THAT SHE DID NOT ALWAYS TAKE HER INSULIN AND HER BLOOD GLUCOSE READINGS WERE IN THE 300S PRIOR TO V-GO INITIATION, BUT HER MOST RECENT READINGS WERE 61, 47, AND 41 MG/DL. CUSTOMER SVC REP ENCOURAGED PT TO CONTACT PHYSICIAN. PT STATED THAT SHE WOULD CONTACT PHYSICIAN THE NEXT DAY. BASED ON PT'S LACK OF CONCERN, CUSTOMER SVC ALSO CONTACTED PHYSICIAN TO ALERT HIM OF THE 3 CONSECUTIVE LOW VALUES FOR BLOOD GLUCOSE AND APPARENT LACK OF PT ACTION TO CORRECT. PHYSICIAN CONTACTED PT THAT EVENING. NO NEGATIVE CLINICAL OUTCOME RESULTED FROM LOW BLOOD GLUCOSE VALUES. PHYSICIAN CONTACTED CUSTOMER SVC ON 3/20 TO REPORT PT RESPONDED TO CORRECTIVE ACTION WHICH WAS AN INSULIN DOSAGE REDUCTION AT MEALTIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-GO (H-PATCH) 20 UNIT BASAL / VALERITA LZG FPA DISPOSABLE INFUSION PUMP LZG VALERITAS, LLC 070820-01

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention