BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 8054257 · Received November 9, 2018

    Report

    Report Number
    3008382007-2018-03109
    Event Type
    Injury
    Date Received
    November 9, 2018
    Report Date
    November 7, 2018
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. LIFESCAN ALSO CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. ANALYSIS WAS NOT POSSIBLE FOR THE RETURNED TEST STRIPS DUE TO UNKNOWN STORAGE AND HANDLING PREVENTING THE ALLEGATION BEING PHYSICALLY INVESTIGATED. 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) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH ULTRA METER READ INACCURATELY HIGH IN COMPARISON TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ADVISED THE CSR THAT IN THE EVENING OF (B)(6) 2018, SHE OBTAINED AN ALLEGED INACCURATELY HIGH READING OF ¿15.7 MMOL/L¿ ON THE SUBJECT METER COMPARED TO HER FEELINGS/NORMAL RESULTS. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH SELF-ADJUSTED INSULIN (UNSPECIFIED TYPE). SHE EXPLAINED SHE INCREASED HER DOSE OF MEDICATION AND TOOK ONE UNIT OF SHORT-ACTING INSULIN, BASED ON THE ALLEGED INACCURATE HIGH READING. THE PATIENT ADVISED THE CSR THAT THREE HOURS LATER SHE ¿HAD A HYPOGLYCEMIC EPISODE¿ AND DEVELOPED A ¿TREMOR AND SWEATINESS¿. SHE EXPLAINED THAT SHE PERFORMED ANOTHER BLOOD GLUCOSE TEST AND OBTAINED A RESULT OF ¿AROUND 3.0 MMOL/L¿. THE PATIENT STATED THAT SHE COULD NOT REMEMBER IF SHE TREATED HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE PATIENT HAD USED THE CORRECT UNIT OF MEASURE AT THE TIME OF TESTING. THE CSR WAS UNABLE TO WALK THE PATIENT THROUGH A CONTROL SOLUTION TEST AS THE PATIENT DID NOT HAVE CONTROL SOLUTION AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON AN INACCURATELY HIGH READING OBTAINED ON THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895659 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4234826

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening