BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3915150 · Received July 7, 2014

    Report

    Report Number
    2939301-2014-16359
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Report Date
    June 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (08/20/2014). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON (B)(4) 2014, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW BATTERY. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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

    FOLLOW-UP#1 (07/11/2014) CORRECTION: SELECTED PRODUCT PROBLEM, DESCRIPTION UPDATED, TEST STRIP LOT #S INVOLVED INCLUDE LOT # #3521207 AND #3531879, UPDATED IMPORTER ADDRESS.

    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 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH PING METER DOES NOT POWER ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT AT 6.30AM ON (B)(6) 2014 THE SUBJECT METER WOULD NOT POWER ON. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN AND SELF-ADJUSTS. AFTER THE ALLEGED PRODUCT ISSUE BEGAN, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿NAUSEOUS¿ BETWEEN 6:30 AND 8:30AM. THEY REPORTED INCREASING THEIR MEDICATION AT 8:30AM, ADMINISTERING ¿ONE DOSE¿ OF HUMALOG. AT THE TIME OF TROUBLESHOOTING THE CCA THAT THE SUBJECT METER TURNED ON WHEN THE POWER BUTTON WAS PRESSED; HOWEVER, DID NOT TURN ON WHEN A TEST STRIP WAS INSERTED. THE PATIENT TRIED TWO DIFFERENT VIALS OF TEST STRIPS WITH DIFFERENT LOT NUMBERS AND THE POWER ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING RULED OUT AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSIONS: THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT SUFFER SIGNS OR SYMPTOMS INDICATIVE OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393994 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3521207

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR