BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2179490 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06354
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K05329. 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 THAT HER ULTRA 2 METER POWERED OFF ABOUT A WEEK AFTER SHE HAD RECEIVED IT. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS; HOWEVER, THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT. MSS WILL BE CLASSIFYING THE COMPLAINT BASED ON THE INITIAL CALL PLACED ON (B)(6) 2011. THE PATIENT MENTIONED THAT THIS SUBJECT METER WAS HER BACK UP METER TO HER ULTRA. WHEN SHE DID NOT HAVE BATTERIES TO TEST ON HER ULTRA METER SHE ATTEMPTED TO TEST ON HER ULTRA 2 METER AND THE METER WOULD NOT POWER ON. JUST PRIOR TO TESTING ON THE AFTERNOON OF EITHER (B)(6) 2011, SHE HAD DEVELOPED SYMPTOMS WHICH CONSISTED OF HEADACHE, NAUSEA, SHAKING, AND NO APPETITE. SHE IMMEDIATELY ATTEMPTED TO TEST ON HER BACK UP METER AND THE METER WOULD NOT POWER ON. SHE THEN SELF-TREATED WITH FOOD/DRINK. THE PATIENT TESTED ON ANOTHER DEVICE; HOWEVER, IT IS UNKNOWN WHAT THE READING WAS. THE METER DID NOT POWER ON BY PRESSING THE POWER BUTTON. THE BATTERIES ON HER ULTRA 2 METER ALSO NEEDED REPLACEMENT; HOWEVER, THE PATIENT DID NOT HAVE THE REPLACEMENT BATTERIES. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, HOW LONG THE PATIENT WAS UNABLE TO TEST ON BOTH DEVICES, LAST READING THE PATIENT OBTAINED ON THE LFS METER AND WHAT READING THE PATIENT OBTAINED ON THE OTHER DEVICE. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SHE WAS UNABLE TO TEST AND DEVELOPED SYMPTOMS AND HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R