BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2885168 · Received December 26, 2012

    Report

    Report Number
    3008382007-2012-08945
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Report Date
    December 22, 2012
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE 510(K) IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/07/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2013 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY. 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2012 ALLEGING THAT THEIR ONE TOUCH PING METER WAS ALLEGEDLY DISPLAYING HIGHER READINGS THAN HER FREESTYLE METER RECENTLY. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT ON (B)(6) 2012 AT AN UNSPECIFIED TIME THE ONE TOUCH PING METER DISPLAYED A READING OF 27.3 MMOL/L ( 491 MG/DL) AND THE FREESTLYE METER DISPLAYED A RESULT OF 19.6 MMOL/L (352 MG/D). THE PATIENT ADJUSTED HER INSULIN BASED ON THE 27.3 MMOL/L RESULT; HOWEVER, DOES NOT RECALL HOW MUCH INSULIN SHE HAD TAKEN. SOON AFTER TESTING HER BLOOD GLUCOSE THE PATIENT DEVELOPED SYMPTOMS OF FEELING SICK TO HER STOMACH. SHE ATE A SANDWICH AND FELT BETTER 10 MINUTES LATER. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. SHE ONLY TESTED AGAIN LATER THAT NIGHT BEFORE GOING TO BED; HOWEVER , DOES NOT RECALL THE READING AND DID NOT FEEL THAT HER READING AT NIGHT WAS INACCURATE. A NORMAL READING FOR THE PATIENT IS AROUND 6.0 MMOL/L. WHILE TROUBLESHOOTING,A QUALITY CONTROL TEST WAS DONE AND THE TEST STRIPS PASSED USING THE CONTROL SOLUTION. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE PATIENT ALSO NOTICED THAT HER INFUSION TEST WAS NOT SET CORRECTLY. THE PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT, SINCE THE PATIENT'S SYMPTOMS ARE NOT SUGGESTIVE OF A SERIOUS INJURY. THE COMPLAINT IS BEING REPORTED SINCE THE METER TO OTHER METER COMPARISON IS GREATER THAN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3331058

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR