BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1832241 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07752
    Event Type
    Injury
    Date Received
    September 13, 2010
    Report Date
    August 23, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (DATE OF BIRTH) NOT PROVIDED.THE 510K # IS K053529.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 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

    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.

    Description of Event or Problem · 1

    ON AUGUST 23, 2010, THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON SEPTEMBER 9, 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT IS TESTED TWICE A DAY AND MANAGES HER DIABETES BY TAKING 20 UNITS OF NOVOLIN 70/30 IN THE MORNING AND AT SUPPER TIME. THE REPORTER CLAIMED SHE ADJUSTS THE AMOUNT OF 70/30 INSULIN THAT SHE ADMINISTERS IF THE PATIENT'S BLOOD GLUCOSE IS RUNNING HIGHER THAN TYPICAL. IN ADDITION, THE REPORTER STATED THAT THE PATIENT IS GIVEN REGULAR INSULIN ON A SLIDING SCALE WHEN HER BLOOD GLUCOSE IS ABOVE "300 MG/DL." THE PATIENT'S DAUGHTER REPORTED THAT THE ALLEGED INACCURACY BEGAN A COUPLE OF MONTHS PRIOR TO CONTACTING LFS. ON UNSPECIFIED DATES/TIMES, THE REPORTER CLAIMED SHE PERFORMED CONSECUTIVE BLOOD GLUCOSE TESTS ON TWO SEPARATE OCCASIONS. ON ONE OF THOSE OCCASIONS SHE OBTAINED READINGS OF "139, 168 AND 188 MG/DL" AND ON A DIFFERENT OCCASION OBTAINED RESULTS OF "152, 133 AND 151 MG/DL" WITH THE SUBJECT METER. THE REPORTER CONFIRMED THE TESTS WERE TAKEN A FEW MINUTES APART FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <=20%. THE REPORTER CLAIMED THAT ON AN UNSPECIFIED DATE/TIME, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT BEGAN TO FEEL SHAKY, NERVOUS, IRRITABLE AND WEAK. THE REPORTER DID NOT RECALL IF THE PATIENT'S BLOOD GLUCOSE WAS TESTED AT THE TIME OF THE SYMPTOMS; HOWEVER, CONFIRMED THAT SHE TREATED HERSELF WITH FOOD AND/OR DRINK IMMEDIATELY AFTER. THE PATIENT'S DAUGHTER DID NOT RECALL HOW MUCH TIME ELAPSED BETWEEN WHEN THE PATIENT'S BLOOD GLUCOSE WAS LAST TESTED WITH THE SUBJECT METER AND WHEN THE SYMPTOMS DEVELOPED. THE REPORTER ALSO DID NOT RECALL THE RESULT OBTAINED. THE PATIENT'S DAUGHTER SUGGESTED THAT THE LOW SYMPTOMS MAY HAVE BEEN AS A RESULT OF POSSIBLY ADMINISTERING AN INCORRECT DOSE OF INSULIN BASED ON A READING OBTAINED WITH THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S DAUGHTER CLAIMS THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A CAROTID STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION. THE TARGET LESION BEING TREATED WAS LOCATED IN THE RIGHT OSTIUM INTERNAL CAROTID. THE LESION WAS 84% STENOSED, 6MM IN DIAMETER AND 21MM LONG. DURING THE INDEX PROCEDURE, THE LESION WAS TREATED WITH A FILTERWIRE EZ AND PLACEMENT OF A CAROTID WALLSTENT. THE FIRST CAROTID WALLSTENT FAILED TO CROSS THE LESION. AN ANGIOPLASTY WAS PERFORMED WITH A 3X20MM STERLING BALLOON. THE FIRST STENT WAS ATTEMPTED TO BE REUSED. THE FILTERWIRE EZ WAS THREADED THROUGH THE TIP OPENING OF THE STENT DELIVERY SYSTEM, HOWEVER COULD NOT PASS THROUGH THE PROXIMAL SHAFT GUIDEWIRE OPENING. A SECOND CAROTID WALLSTENT ATTEMPTED TO CROSS THE LESION AND WAS UNABLE TO PASS THROUGH THE STENOSIS. THE DEVICE WAS REMOVED AND THE LESION WAS RE-ANGIOPLASTIED WITH A 5X20MM STERLING BALLOON. THE STENT WAS THREADED ON TO THE FILTERWIRE EZ AND ENCOUNTERED THE SAME ISSUE AND WOULD NOT PASS THROUGH THE PROXIMAL SHAFT OPENING OF THE STENT SYSTEM. A THIRD CAROTID WALLSTENT WAS SUCCESSFULLY IMPLANTED. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 5%. POST PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION. BLOOD PRESSURE WAS 86/33. NO ACTION WAS TAKEN FOR THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 1 DAY LATER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS CLOSED TO INSERT AND AFTER INSERTION IT WOULD NOT OPEN. NO OTHER DETAILS WERE PROVIDED. NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3025984

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R