BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1843071 · Received September 23, 2010

    Report

    Report Number
    2939301-2010-08326
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A 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.510K#: K061118.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING INACCURATELY ERRATIC READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6), 2010 THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 212 MG/DL AND 125 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES OF EACH OTHER. BASED ON THESE METER READINGS, THE PATIENT TOOK AN INCREASED DOSE OF INSULIN, SEVEN UNITS HUMALOG INSULIN. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND "SEEING SPOTS". THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE WAS CORRECT AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON ELEVATED METER READINGS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE JAMMED IN THE CLOSED POSITION AND THE JAWS WOULD NOT OPEN AFTER FIRING. THEY WERE ABLE TO GET THE JAWS OPEN TO REMOVE THE DEVICE. IT IS UNKNOWN HOW THEY WERE OPENED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY IMPACT TO THE PATIENT. THESE ARE ALL THE DETAILS CURRENTLY KNOWN.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE CAP OF HER ONETOUCH LANCING DEVICE WAS MISSING. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6), 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT SHE LOST THE CAP TO THE LANCING DEVICE APPROXIMATELY 4 MONTHS PRIOR TO CONTACTING LFS. THE PATIENT TESTS ONCE A DAY AND MANAGES HER DIABETES WITH ORAL MEDICATION. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT SHE DISCONTINUED TESTING HER BLOOD GLUCOSE; HOWEVER, CONTINUED TO TAKE HER USUAL DOSE OF ORAL MEDICATION. ON AN UNSPECIFIED DAY IN (B)(6), 2010, AFTER SHE HAD LOST THE CAP, THE PATIENT REPORTED FEELING SWEATY AND SHAKY. IN RESPONSE TO THE SYMPTOMS, THE PATIENT REPORTED THAT SHE TREATED HERSELF WITH FOOD AND DRINK AND CONFIRMED FEELING BETTER AFTERWARDS. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2969262

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening