BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1854016 · Received October 5, 2010

    Report

    Report Number
    2939301-2010-08790
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) # IS K082590. 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

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY REPORTER/ MOTHER CONTACTED LFS ON (B)(6) 2010 ALLEGING THAT HER DAUGHTER'S ONE TOUCH PING METER WOULD NOT POWER OFF. THE MOTHER MENTIONED THAT THE METER STATED " PC " FROZEN . SHE TRIED REPLACING THE BATTERIES; HOWEVER, THE PC IS STUCK ON METER. MOTHER MENTIONED THAT THE REPORTED ISSUE BEGAN AT AROUND 8:30AM ON (B)(6) 2010. SHE MENTIONED THAT PRIOR TO TESTING HER DAUGHTER WAS NOT FEELING WELL AND HAD BEEN VOMITING. MOTHER NEEDED TO TEST HER DAUGHTER'S BLOOD GLUCOSE. MOTHER MENTIONED THAT SHE HAD A SPARE METER AND WOULD TEST HER DAUGHTER USING THE SPARE METER. MOTHER MENTIONED THAT ON (B)(6) 2010 HER DAUGHTER'S INSULIN CARTRIDGE FELL OFF THE PUMP, SO HER DAUGHTER DID NOT GET ANY INSULIN AND WHEN THE REPORTER TESTED HER DAUGHTER ON THE MORNING OF (B)(6) 2010 AROUND 7:15AM, HER BLOOD GLUCOSE READING WAS LOWER THAN WHAT THE REPORTER HAD EXPECTED. ISSUE WAS NOT RESOLVED VIA TROUBLESHOOTING. PRODUCT WAS REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT, SINCE THE PATIENT EXHIBITED SYMPTOMS PRIOR TO TESTING AND WAS ABLE TO OBTAIN A BLOOD GLUCOSE PRIOR TO THE SYMPTOMS. THE COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ISSUE WITH THE METER WAS NOT RESOLVED.

    Description of Event or Problem · 1

    USER REPORTED THAT SHE WAS AT AN EVENT ON ((B)(6) 2010) AND SHE DECIDED TO SHOW PEOPLE HOW THE DEVICE DITHERS IN BALANCE FUNCTION. USER STATED THAT SOMEONE LIGHTLY PUSHED/TAPPED THE DEVICE AND THAT THE DEVICE MOVED FORWARD VERY FAST AND WENT APPROX 8-9 FEET. USER STATED THAT, WHEN THE DEVICE STOPPED, SHE FELL FROM THE DEVICE. USER STATED THAT SHE WAS NOT WEARING THE PROVIDED LAP BELT AT THE TIME OF THE EVENT. USER STATED THAT, WHILE IN BALANCE, THE DEVICE FELL OVER FORWARD. USER STATED THAT SHE WAS TAKEN BY AMBULANCE TO THE ER FOR SHOULDER PAIN, NECK PAIN AND A BROKEN NOSE. THE USER DID NOT HAVE X-RAYS. AT THE TIME THAT THE EVENT WAS REPORTED TO THE COMPANY ON (B)(6) 2010, THE USER STATED THAT SHE HAD A BLACK EYE AND MAY SEEK DENTAL CARE. USER ALSO STATED THAT SHE HIT HER FOREHEAD, HAS RUG BURN ON HER FACE, NOSE, AND FOREHEAD AND THAT HER GLASSES WERE BROKEN. THE DEVICE REMAINS WITH THE USER FOR HER CONTINUED USE. THIS REPORT RELATES TO INDEPENDENCE TECHNOLOGY COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3044317

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR