BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3951601 · Received July 23, 2014

    Report

    Report Number
    2939301-2014-18203
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 14, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    FOLLOW-UP # 1 DEVICE EVALUATION: THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND FURTHER 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. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. PERFORMANCE TESTING WITH BLOOD WAS PERFORMED ON THE RETAIN TEST STRIPS. THE RETAIN TEST STRIPS PASSED THE PERFORMANCE TESTING 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT¿S CARE GIVER (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH PING METER READ INACCURATELY HIGH AGAINST ANOTHER DEVICE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN IN (B)(6) 2014. AT AN UNSPECIFIED DATE/TIME THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿317MG/DL¿ WITH THE SUBJECT METER AND ¿192MG/DL¿ WITH EITHER THE ONETOUCH ULTRAMINI METER OR ONETOUCH VERIO IQ METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT MANAGES THEIR BLOOD GLUCOSE WITH INSULIN PUMP THERAPY; HOWEVER, THE REPORTER DENIED TAKING ANY ACTION IN REGARDS TO THE PATIENT¿S DIABETES MANAGEMENT AFTER THE ALLEGED ISSUE OCCURRED. ACCORDING TO THE CSR¿S DOCUMENTATION, A FEW MINUTES AFTER THE PRODUCT ISSUE OCCURRED, THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF SHAKING AND SWEATING. IT IS NOT SPECIFIED IF THE REPORTER ADMINISTERED TREATMENT AFTER THE REPORTED SYMPTOMS OCCURRED. THE REPORTER INDICATED THE PATIENT¿S BLOOD GLUCOSE WAS TESTED WITH ANOTHER DEVICE; HOWEVER, THE BLOOD GLUCOSE READING, TYPE OF DEVICE, AND WHEN THE TEST OCCURRED ARE NOT KNOWN. PER THE REPORTER, SOMETIME BETWEEN (B)(6) 2014 THE PATIENT¿S PHYSICIAN ADVISED TO NO LONGER USE THE SUBJECT METER; NO OTHER MEDICAL INTERVENTION WAS SPECIFIED. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER¿S BOOKLET) SAMPLE SITE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430129 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3636139

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening