BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1771806 · Received July 28, 2010

    Report

    Report Number
    2939301-2010-05972
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 9, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS THREE TIMES A DAY AND MANAGES HER DIABETES WITH 5MG OF GLIPIZIDE IN THE MORNING AND EVENING. THE PATIENT DOES NOT RECALL WHEN THE ALLEGED ISSUE FIRST BEGAN; HOWEVER, ON THE MORNING OF (B)(6) 2010 (TIME NOT KNOWN), THAT PATIENT INDICATED SHE OBTAINED A BLOOD GLUCOSE RESULT IN THE "120'S" WITH THE SUBJECT METER AND CONSUMED HER USUAL DOSE OF MEDICATION. THE PATIENT INDICATED SHE WOULD OCCASIONALLY COMPARE THE SUBJECT METER AGAINST ANOTHER DEVICE; HOWEVER, DOES NOT RECALL IF SHE TESTED AGAIN WITH ANOTHER DEVICE THAT MORNING. PRIOR TO THE ALLEGED ISSUE, THE PATIENT STATED THAT IN THE SPAN OF TWO WEEKS (DATE/TIME NOT KNOWN) SHE OBTAINED BLOOD GLUCOSE RESULTS BETWEEN "120-126 MG/DL" WITH THE SUBJECT METER; HOWEVER, WOULD IMMEDIATELY AFTER OBTAIN A RESULT IN THE "80'S" WHEN SHE COMPARED THE SUBJECT METER WITH ANOTHER DEVICE. THE PATIENT INDICATED SHE WOULD CONTINUE TO TAKE HER USUAL DOSE OF MEDICATION, REGARDLESS WHAT THE RESULT WAS WITH THE SUBJECT METER. AT APPROXIMATELY 12 PM ON (B)(6) 2010, THE PATIENT CLAIMED SHE EXPERIENCED SYMPTOMS OF SHAKING, COLD SWEATS, AND FELT AS IF SHE WAS GOING TO PASS OUT. APPROXIMATELY 10-15 MINUTES AFTER THE ONSET OF HER SYMPTOMS, THE PATIENT STATED SHE OBTAINED A RESULT IN THE "80'S" WITH THE SUBJECT METER. BASED ON HER SYMPTOMS, THE PATIENT INDICATED SHE DISAGREED WITH THE RESULT AND WITHIN TWENTY MINUTES THE PATIENT STATED WITH TESTED WITH ANOTHER DEVICE AND OBTAINED A RESULT IN THE "50'S" (A READING THE PATIENT CLAIMED CORRELATED MORE WITH HER SYMPTOMS). THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING A PEANUT BUTTER SANDWICH AND FELT BETTER 5-10 MINUTES LATER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER. HOWEVER, THE CSR NOTED THAT THE CONTROL SOLUTION TEST DID NOT PASS DURING TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3010118

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening