BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1832448 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07769
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Report Date
    August 24, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT; 510(K)# IS K073231.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    THE PT ALLEGED THAT THE PUMP OVER DELIVERED INSULIN. HE REPORTED THAT THE PUMP INDICATED 8 UNITS REMAINING WHEN HIS BLOOD GLUCOSE WAS 175 MG/DL AND 1 HOUR LATER THE PUMP INDICATED 1 UNIT REMAINING WHEN HIS BLOOD GLUCOSE WAS 130 MG/DL. THE PT STATED THAT AT THE TIME OF THE INCIDENT (BETWEEN APPROX 7:00 PM AND 8:00 PM) HIS BASAL RATE WAS 1.0 UNIT/HOUR AND HE DID NOT DELIVER ANY INSULIN VIA BOLUS. REVIEW OF THE PUMP HISTORY BY THE PT INDICATED NO BOLUS DELIVERIES AFTER 12:27 AM ON (B)(6) 2010 AT WHICH TIME 5 UNITS WERE DELIVERED. TOTAL BASAL DELIVERY FOR (B)(6) 2010 WAS RECORDED AT 28.2 UNITS AROUND 8:00 PM. THE PT NOTED THAT HE USES 4 BASAL PROGRAMS AND SWITCHES BETWEEN PROGRAMS BASED ON CURRENT BLOOD GLUCOSE READINGS; HE CHANGED TO A NEW BASAL PROGRAM IMMEDIATELY PRIOR TO THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2964214

    Patients

    Seq Age Sex Outcome Treatment
    1