BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1813341 · Received August 24, 2010

    Report

    Report Number
    2939301-2010-07095
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 31, 2010
    Report Date
    July 31, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURESPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRALINK METER DOES NOT TURN ON. ON (B)(6) 2010, THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO CLARIFY THE INFORMATION OBTAINED DURING THE INITIAL PHONE CALL. THE PATIENT TESTS HER BLOOD GLUCOSE FREQUENTLY TO MANAGE HER DIABETES PER THE INSULIN PUMP. THE PATIENT REPORTEDLY WENT THROUGH ONE EVENING PRIOR TO DINNER WITHOUT OBTAINING A BLOOD GLUCOSE TEST TO MANAGE HER DIABETES DUE TO THE ONSET OF THE POWER ISSUE ON (B)(6) 2010 BEFORE DINNER. ON THE EVENING OF (B)(6) 2010, THE PATIENT BOLUS HER INSULIN BASED ON THE CARBOHYDRATE INTAKE FOR DINNER AND MAINTAINED HER BASAL INSULIN RATE. IN THE MORNING, THE PATIENT WOKE UP NOT FEELING WELL. SHE ATTEMPTED TO TEST WITH THE SUBJECT METER FIRST THING IN THE MORNING BUT WAS STILL UNABLE TO OBTAIN A BLOOD GLUCOSE READING. 30 MINUTES AFTER THE PATIENT WOKE UP, HER SYMPTOMS PROGRESSED TO SYMPTOMS DESCRIBED AS "SHAKY, SLEEPY, AND SLURRY." SELF TREATMENT WITH FOOD WAS TAKEN AT THE TIME OF CONCERN. HER SYMPTOMS ABATED WITHIN 30 MINUTES. THE PATIENT FELT AS THOUGH THE ALLEGED LOW EPISODE COULD HAVE BEEN PREVENTED HAD SHE BEEN ABLE TO OBTAIN HER BLOOD GLUCOSE FIRST THING IN THE MORNING. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3034524

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R