BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3200876 · Received July 2, 2013

    Report

    Report Number
    2183996-2013-01195
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 26, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT PUMP: THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE ALARM FUNCTIONS OF THE PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. HISTORY LIST: ON (B)(6) 2013 FROM 15:18 TO 15:35, THE PUMP WAS IN STOP MODE (LONGEST TIME). DURING THIS TIME THE PUMP DELIVERED NO INSULIN. THE DAILY TOTAL (DAILY BASAL RATE AND BOLUSES) WERE BETWEEN 4.6 IU AND 17.9 IU. THE DAILY BASAL RATE WAS DELIVERED. BOLUSES WERE PROGRAMMED AND DELIVERED. INFUSION SET: THE TWO RETURNED USED TRANSFER SETS WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED THAT ON (B)(6) 2013 THE PATIENT WENT TO THE DIABETES SPECIALIST TO INFORM HIM THAT SHE HAS HAD SEVERAL HYPOGLYCEMIA EPISODES. MOTHER STATED THE DIABETES SPECIALIST DECIDED TO CHANGE THE TOTAL SUM OF BASAL RATE AND INTERESTINGLY HE INCREASED THE TOTAL SUM OF BASAL RATE. MOTHER REPORTED THAT SINCE THAT TIME THE PATIENT'S BLOOD GLUCOSE LEVEL WENT UP TO 200-300 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. MOTHER STATED SHE CHANGED THE COMPLETE ACCESSORIES; BLOOD GLUCOSE LEVEL REMAINED ELEVATED. MOTHER REPORTED CORRECTING SUCCESSFULLY WITH A PEN. PATIENT IS DISABLED. MOTHER STATED IN THE NIGHT OF (B)(6) 2013, THE PATIENT FELT SICK AND HAD TO VOMIT SEVERAL TIMES AND WAS ALSO SLEEPY. MOTHER REPORTED SHE CALLED THE DIABETES SPECIALIST AND HE RECOMMENDED CORRECTION VIA PEN. MOTHER STATED SHE THEN TOOK THE PATIENT TO THE HOSPITAL WHERE THE PATIENT RECOVERED VERY FAST. PATIENT'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. MOTHER REPORTED THE PATIENT DID NOT RECEIVE ANY TREATMENT; ONLY CONTROLLING THE BLOOD GLUCOSE LEVEL EVERY HOUR. MOTHER REPORTED SHE AND THE DIABETES SPECIALIST THINK THE INFUSION DEVICE DELIVERY IS TOO LOW INSULIN. MOTHER WILL SWITCH PATIENT TO THE BACKUP INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303235 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 010 YR Hospitalization| R