BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4183364 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27862
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Report Date
    October 10, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/25/2015 DEVICE EVALUATION.THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 11/6/2014 AND 1/8/2015, EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/4/2014 AND 1/19/2015 RESPECTIVELY WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED.THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. 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, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING INACCURATE LOW READINGS ON THE LIFESCAN ULTRAPING METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE REPORTER THAT THE ALLEGED INACCURACY ISSUE BEGAN ON ¿(B)(6) 2014 AT 9:15AM¿. ON THE SAME DAY AT 9:42AM THE REPORTED STATED THE PATIENT OBTAINED ALLEGED INACCURATE LOW BLOOD GLUCOSE RESULTS OF ¿22 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿114MG/DL ON ANOTHER METER (ACCU-CHEK) PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH AN INSULIN PUMP AND DENIED TAKING ANY ACTION IN RESPONSE TO THE PRODUCT ISSUE. THE REPORTER STATED THAT THE PATIENT EXPERIENCED SYMPTOMS OF ¿SHAKING AND NERVOUS¿ PRIOR TO THE METER ISSUE AND SELF-TREATED WITH FOOD AND/OR DRINK ON ¿(B)(6) 2014 AT 9:35AM¿. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT AN APPROVED SITE WAS USED TO OBTAIN THE RESULT, THE CORRECT TESTING PROCEDURE AND UNIT OF MEASURE WAS USED AT THE TIME OF TESTING. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, HE WAS SYMPTOMATIC PRIOR TO OBTAINING THE ALLEGED INACCURATE RESULTS. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED METER/PRODUCT ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664056 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3633360

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR