BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5920194 · Received September 1, 2016

    Report

    Report Number
    3008382007-2016-45092
    Event Type
    Injury
    Date Received
    September 1, 2016
    Date of Event
    August 20, 2016
    Report Date
    August 24, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER (DAUGHTER) FOR THE PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH COMPARED TO FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2016, 08:45AM. SHE CLAIMED THAT THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE RESULT OF "305, 230, 224, 214, 240, 222, 195, 227 AND 284 MG/DL" ON THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISES AND REPORTED THAT ON AN UNSPECIFIED TIME PRIOR TO THE START OF THE ALLEGED PRODUCT ISSUE SHE WAS EXPERIENCING SYMPTOMS OF WEAK DIZZY AND TIRED. THE REPORTER STATED THAT THE PATIENT ATTENDED ER AND RECEIVED 5 UNITS OF HUMULIN INSULIN FROM A HEALTH CARE PROFESSIONAL (HCP) ON (B)(6) 2016 AT 8PM AND ON (B)(6) 2016; AT 12:30AM SHE RECEIVED 5 UNITS OF HUMULIN AND OBTAINED A BLOOD GLUCOSE RESULT OF 130MG/DL ON THE HOSPITAL METER. AT THE TIME OF TROUBLE SHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE TEST STRIPS WERE STORED CORRECTLY AND NOT EXPIRED. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO COMPLETE A TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT DID NOT DEVELOP SYMPTOMS THE PATIENT REPORTEDLY RECEIVED HCP INTERVENTION FOR SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572412 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4016535

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening