BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2200321 · Received August 11, 2011

    Report

    Report Number
    2939301-2011-07225
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TH ESUBJECT DEVICE HAS BEEN RETURNED TO LFS. PRODUCT ANALYSIS TESTING IS ANTICIPATED BUT NOT YET BEGUN. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/07/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. A SECONDARY ISSUE WAS ALSO NOTED, THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. 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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH PING METER REMOTE WAS DISPLAYING AN "ERROR 1" MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT CLAIMED THAT ON (B)(6) 2011 AT APPROXIMATELY 11AM, SHE WAS UNABLE TO CHECK HER BLOOD GLUCOSE ON THE SUBJECT DEVICE BECAUSE OF AN "ERROR 1" MESSAGE. PER THE ONETOUCH PING OWNER'S MANUAL, AN ERROR 1 MAY MEAN THAT A PROBLEM WITH THE METER HAS OCCURRED. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH INSULIN USING AN INSULIN PUMP AND TESTS "SEVERAL TIMES" PER DAY. SHE DENIED TAKING ANY ACTION AT THE TIME OF THE ALLEGED PRODUCT ISSUE AND DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT CLAIMED APPROXIMATELY 7 HOURS LATER, JUST AS THE SHE WAS REPORTING THE ISSUE TO ANIMAS CUSTOMER SUPPORT, SHE BEGAN TO FEEL "DIZZY AND WAS SWEATING." THE PATIENT CLAIMED SHE ASSOCIATED THE SYMPTOMS WITH LOW BLOOD GLUCOSE AND TREATED HERSELF WITH FOOD IMMEDIATELY AFTER THE SYMPTOMS DEVELOPED. APPROXIMATELY 2 HOURS LATER, SHE TESTED ON HER UNCLE'S METER (UNKNOWN TYPE) BUT COULD NOT RECALL WHAT THE GLUCOSE READING WAS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND SINCE ERROR 1 IS TYPICALLY NOT RESOLVED WITH TRAINING, A REPLACEMENT WAS SENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3047541

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Life Threatening| R