BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4260718 · Received November 19, 2014

    Report

    Report Number
    2939301-2014-31170
    Event Type
    Injury
    Date Received
    November 19, 2014
    Report Date
    November 10, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/10/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 11/21/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/1/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (12/26/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 12/15/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/15/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. IN ADDITION, THE REPORTER ALSO STATED THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THESE COMPLAINTS WERE CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER ISSUES FIRST OCCURRED ¿5-6 WEEKS¿ PRIOR TO THE ALERT DATE OF (B)(6) 2014. THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿167, 194, 153 AND 178MG/DL¿ ON THE SUBJECT METER WHICH WERE HIGHER THAN THEIR FEELINGS/NORMAL READINGS. IT WAS ALSO AT THIS TIME THAT THE REPORTER STATED THAT THE READINGS OF ¿194 AND 167MG/DL¿ OBTAINED ON THE SUBJECT METER WERE ERRATIC. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (TYPE AND DOSAGE UNKNOWN) AS WELL AS DIET AND/OR EXERCISE. IN RESPONSE TO THE ALLEGED INACCURATELY HIGH SUBJECT METER READINGS THE PATIENT STATED THAT THEY HAD LESS FOOD/DRINK ¿4-5 WEEKS¿ PRIOR TO THE ALERT DATE. WITHIN A WEEK THE PATIENT STATED THAT THEY FELT ¿SWEATY, COLD, RED IN THE FACE, HAD STOMACH ACHE, A HEADACHE AND WAS SHAKY¿. IN RESPONSE TO FEELING THIS WAY THE PATIENT SELF-TREATED BY EATING MORE FOOD/DRINK AND CLAIMED TO HAVE FELT WELL AGAIN AFTER 10 MINUTES. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE CORRECT UNIT OF MEASURE WAS SET ON THE SUBJECT METER AND THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT. THE ALLEGED INACCURATE ERRATIC RESULTS WERE OBTAINED WITH GREATER THAN 20 MINUTES BETWEEN THEM, HOWEVER. THE PATIENT¿S PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED BLOOD GLUCOSE READINGS ON THE SUBJECT METER WHICH THEY FELT WERE INACCURATELY HIGH AND ERRATIC, TOOK ACTION IN RESPONSE TO THESE RESULTS, AND THEN SUFFERED SYMPTOMS SUGGESTIVE OF SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUES BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751351 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3592921

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening