BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1811769 · Received August 23, 2010

    Report

    Report Number
    2939301-2010-07084
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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.

    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 A LOW/DEAD BATTERY. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE A BALLOON TEAR OCCURRED. THE 100% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 1.50X8MM APEX PUSH BALLOON WAS INFLATED ONE TIME TO 4 ATMS AT WHICH POINT BLOOD WAS NOTICED INSIDE THE INFLATION DEVICE. UPON SUCCESSFUL REMOVAL OF THE BALLOON CATHETER A VERTICAL TEAR WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH ULTRA METER WOULD NOT POWER ON. ON (B)(6) 2010 THE SR. MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE PATIENT'S WIFE AND OBTAINED SOME ADDITIONAL INFORMATION; HOWEVER WAS UNABLE TO SPEAK WITH THE PATIENT. ON (B)(6) 2010 AT 10:00 AM, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF "HI MG/DL" (GREATER THAN 600 MG/DL) ON THE REPORTED METER. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF NERVOUSNESS AND BLURRED VISION. BASED ON THE ELEVATED METER READING, THE PATIENT TOOK AN INCREASED DOSE OF INSULIN, 30 UNITS NOVOLOG INSULIN INSTEAD OF 20 UNITS. THE PATIENT CONTACTED HIS PHYSICIAN BUT WASN'T ABLE TO REACH HIM. DURING THE TROUBLESHOOTING TELEPHONE CALL WITH LFS, THE PATIENT DISCOVERED THE REPORTED METER WOULD NOT POWER ON; HE WAS UNABLE TO RETEST HIS BLOOD GLUCOSE LEVEL. THE PATIENT ATE FOOD, AND TOOK HIMSELF TO THE EMERGENCY ROOM TO HAVE HIS BLOOD GLUCOSE LEVEL TESTED, SINCE HE WAS UNABLE TO CONTACT HIS PHYSICIAN. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S BLOOD GLUCOSE READING AS TESTED IN THE EMERGENCY ROOM, THE TREATMENT RECEIVED IF ANY, HIS EXPECTED BLOOD GLUCOSE READINGS AND HIS INSULIN REGIMEN. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE CORRECT. THE CUSTOMER CARE ADVOCATE ALSO DETERMINED THE PATIENT HAD NOT REPLACED THE METER'S BATTERY AS RECOMMENDED BY THE MANUFACTURER. THE ISSUE WAS NOT RESOLVED, AS THE PATIENT DID NOT HAVE A NEW REPLACEMENT BATTERY AVAILABLE. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT HAD NOT REPLACED THE METER'S BATTERY AS RECOMMENDED. THE PATIENT ALLEGEDLY WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVELS AFTER TAKING AN INCREASED DOSE OF INSULIN DUE TO THE METER POWER ISSUE, AND RECEIVED EMERGENCY MEDICAL ATTENTION. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2975442

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening