BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2060323 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03133
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    April 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/23/2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011, RESPECTIVELY. THE METER AND TEST STRIPS BOTH PASSED TESTING WITH NO FAULTS FOUND AGAINST THE ALLEGED COMPLAINT. AN UNREPORTED ISSUE WAS NOTED FOR THE RETURNED TEST STRIPS: EXTRA TEST STRIPS WERE FOUND IN THE TEST STRIP VIAL. TESTING ON RETAIN TEST STRIPS WAS ALSO PERFORMED ON (B)(6) 2011 WITH NO FAULTS FOUND. 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELING/ NORMAL RESULT(S). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011; HOWEVER THE PATIENT REFUSED TO ANSWER ANY ADDITIONAL FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 (TIME NOT SPECIFIED). ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "200, 258, AND 250 MG/DL" WITH THE SUBJECT METER. THE PATIENT'S TESTING FREQUENCY IS NOT SPECIFIED; HOWEVER, THE PATIENT INDICATED HE MANAGES HIS DIABETES WITH NOVOLOG AND LANTUS (DOSAGES NOT SPECIFIED). ACCORDING TO THE CSR'S DOCUMENTATION, IN RESPONSE TO THE PRODUCT ISSUE, THE PATIENT ALLEGEDLY INCREASED HIS MEDICATION AND "DOUBLED UP ON HIS LANTUS AND NOVOLOG" (DATE/TIME AND DOSAGE NOT KNOWN). ON AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF LOW BLOOD GLUCOSE (SPECIFYING SWEATING AND SHAKING); IT IS NOT KNOWN IF THE PATIENT TESTED HIS BLOOD GLUCOSE PRIOR TO OR AT THE ONSET OF HIS SYMPTOMS. IT IS ALSO NOT KNOWN WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED FOLLOWING THE ALLEGED METER ISSUE, IT IS NOT KNOWN WHEN THE PATIENT'S SYMPTOMS IMPROVED, AND IT IS NOT KNOWN IF THE PATIENT RETESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AND/OR WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3071885

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening