BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 4919509 · Received July 2, 2015

    Report

    Report Number
    3003442380-2015-00009
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    October 31, 2014
    Report Date
    July 1, 2015
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RELEVANT TESTING COULD BE PERFORMED. SINCE THE LOT NUMBER WAS NOT AVAILABLE, THE BATCH RECORDS AND THE COMPLAINT DATABASE COULD NOT BE REVIEWED FOR RELEVANT DEVIATIONS AND SIMILAR COMPLAINTS. WE HAVE NOT BEEN ABLE TO COLLECT MORE INFORMATION FROM OUR DISTRIBUTOR. NO LOT NUMBER AVAILABLE. HOSPITAL NAME UNKNOWN. NO INFORMATION IF WHETHER THE USED DEVICE WILL BE RETURNED FOR INVESTIGATION. UNOMEDICAL HEREBY CONSIDER THIS CASE TO BE CLOSED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: IT IS ALLEGED BY (B)(6) LAWYER THAT THE FOLLOWING OCCURRED. "(B)(6) HAS TYPE 1 DIABETES. HE WAS USING A MEDTRONIC 530G INSULIN PUMP WITHOUT A CONTINUOUS GLUCOSE MONITOR. HE WAS USING QUICK-SET MMT-397 AND RESERVOIR MMT-332A. IN THE EVENING OF (B)(6) 2014, HIS BLOOD GLUCOSE BECAME ELEVATED INTO THE MIDDLE-400S MG/DL WHILE USING HIS PUMP. IN THE MORNING OF (B)(6) HIS BLOOD GLUCOSE RISE TO 570 MG/DL. AT HIS PHYSICIAN'S ADVICE, HE INCREASED HIS BASAL RATE. THIS WAS INEFFECTIVE IN LOWERING HIS BASAL RATE. THIS WAS INEFFECTIVE IN LOWERING HIS BLOOD GLUCOSE. HE THEN INJECTED HIMSELF WITH INSULIN BY SYRINGE, WHICH DECREASED HIS BLOOD GLUCOSE TO 370 MG/DL. THE FOLLOWING MORNING, (B)(6) HIS BLOOD GLUCOSE HAD RISEN TO 532 MG/DL. BY THE TIME HE REACHED THE HOSPITAL, HIS BLOOD GLUCOSE (PER TESTING CONDUCTED AT THE HOSPITAL) WAS 738 MG/DL. AS A RESULT OF THIS INCIDENT, MR. (B)(6) HAD TO BE PUT IN A MEDICALLY INDUCTED COMA. HE WAS HOSPITALIZED FOR FIVE WEEKS. HE CONTINUES TO HAVE DIFFICULTY WITH BALANCE, REQUIRES A WALKER, AND IS UNDERGOING PHYSICAL THERAPY AND OCCUPATIONAL THERAPY AT HOME." SUBJECT: PARADIGM PUMP TESTING. WE HAVE THE PUMP ITSELF, BUT I DO NOT BELIEVE THE RESERVOIR OR INFUSION SET THAT WERE IN USE AT THE TIME OF THE INCIDENT WERE ABLE TO BE LOCATED. THE BATTERY IS ALREADY DEAD. NO DATA HAS BEEN DOWNLOADED FROM THE PUMP, NOR HAVE THE ERRORS BEEN CLEARED, SINCE MR. (B)(6) INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431661 QUICK-SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MMT-397 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| S