BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1588391 · Received January 27, 2010

    Report

    Report Number
    6000001-2010-00096
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT CONTAINS NO PATIENT INVOLVEMENT. (B) (4)

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF THE STOP KEY DOES NOT WORK WAS CONFIRMED. THE REPORTED CONDITION IS DUE TO SMALL CUT FOUND ON THE STOP KEY TRACE, AND FLUID INGRESS AND CORROSION FOUND ON THE OPEN AND LED TRACES. UPON THE COMPLETION OF BAXTER'S INVESTIGATION OF THIS REPORT, THE DEVICE WILL BE ROUTED TO OUR SERVICE DEPARTMENT WHERE APPROPRIATE SERVICING WILL BE COMPLETED PRIOR TO THE DEVICE BEING RETURNED TO THE CUSTOMER. THERE IS AN ONGOING CAPA INVESTIGATION, (B) (4) ASSOCIATED WITH THIS REPORT. (B) (4)

    Description of Event or Problem · 1

    ON JANUARY 4, 2010, THE FACILITY'S BIOMEDICAL ENGINEER REPORTED TO BAXTER GLOBAL TECHNICAL SERVICES, ONE COLLEAGUE CX VOLUMETRIC INFUSION PUMP IN WHICH THE STOP KEY DOES NOT WORK. THE REPORTED CONDITION WAS IDENTIFIED DURING BIO-MED SERVICE. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE (B) (4) CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO HER FEELINGS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT FOR FOLLOW-UP QUESTIONS. THE MSS REVIEWED THE CALL AND CLASSIFIED THIS COMPLAINT BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON THE EVENING OF (B)(6) 2010 WHEN THE PATIENT REPORTEDLY TESTED WITH THE SUBJECT METER TWO TO THREE HOURS AFTER HER DINNER AND OBTAINED A RESULT OF "OVER 400 MG/DL." IT IS NOT KNOWN WHAT READINGS THE PATIENT WAS OBTAINING FROM THE ALLEGED METER PRIOR TO WHEN THE ISSUE STARTED. THE CCA DOCUMENTED THAT THE PATIENT MANAGES HER DIABETES WITH DIET AND INSULIN (SELF-ADJUSTER). THE PATIENT REPORTED THAT SINCE THE DUE THE ALLEGED READING, SHE ADMINISTERED AN UNSPECIFIED DOSE OF INSULIN BASED ON HER PRESCRIBED SLIDING SCALE. THIRTY MINUTES AFTER OBTAINING THE ALLEGED HIGH METER READING, THE PATIENT CLAIMED THAT SHE BECAME "SHAKY." THE PATIENT STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AT THE ONSET OF HER SYMPTOM AND OBTAINED A BLOOD GLUCOSE RESULT OF "38 MG/DL." THE PATIENT STATED THAT SHE TREATED HERSELF WITH A DRINK. IT IS NOT KNOWN IF THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE ON ANY METER AFTER THE TREATMENT. THE CCA DOCUMENTED THAT THE PATIENT DID HAVE A CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST WITH THE SUBJECT METER AT THE TIME OF THE CALL. REPLACEMENT METER AND SUPPLIES WERE SENT TO THE PATIENT. THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED HER INSULIN MEDICATION BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1