BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 3251400 · Received July 29, 2013

    Report

    Report Number
    2183996-2013-01408
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    August 23, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED WITHIN THE ALARM FUNCTION TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. ALL PROGRAMMED BOLUSES WERE DELIVERED. ALL ERRORS AND WARNINGS ARE TRIGGERED CORRECTLY BY THE PUMP. CONSUMABLES: THE ADAPTER PASSED THE OPTICAL INSPECTION. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT ON (B)(6) 2013 AT 3 PM, HE EXPERIENCED A BLOOD GLUCOSE LEVEL OF 262 MG/DL; TOOK CORRECTION OF 4 UNITS OF INSULIN VIA THE INFUSION DEVICE. PATIENT STATED AT 6:20 PM HIS BLOOD GLUCOSE LEVEL WAS 190 MG/DL; TOOK CORRECTION OF 4 UNITS OF INSULIN VIA THE INFUSION DEVICE. PATIENT REPORTED THAT ON (B)(6) 2013 AT 3 PM, HIS BLOOD GLUCOSE LEVEL WAS 206 MG/DL; HE TOOK CORRECTION OF 4 UNITS OF INSULIN VIA THE INFUSION DEVICE. PATIENT STATED AT 4:35 PM HIS BLOOD GLUCOSE LEVEL WAS 169 MG/DL; HE TOOK CORRECTION AGAIN WITH 4 UNITS OF INSULIN VIA THE INFUSION DEVICE. PATIENT REPORTED AT 6:25 PM HIS BLOOD GLUCOSE LEVEL WAS 115 MG/DL AND THEN HE CHANGED THE INSULIN CARTRIDGE. PATIENT STATED ON (B)(6) 2013 HIS BLOOD GLUCOSE LEVEL IN THE MORNING WAS 169 MG/DL; HE CHANGED THE INFUSION DEVICE, ADAPTER, INFUSION SET TUBING AND CANNULA. PATIENT REPORTED HIS BLOOD GLUCOSE WENT TO A NORMAL LEVEL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT STATED HE THINKS THE INFUSION DEVICE DELIVERS TOO LOW INSULIN. PATIENT REPORTED HE WAS ABLE TO GET HIS BLOOD GLUCOSE LEVEL UNDER CONTROL BY HIMSELF. NO FURTHER INFORMATION IS AVAILABLE. 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
    353464 ACCU-CHEK D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR