BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2116964 · Received June 8, 2011

    Report

    Report Number
    2939301-2011-04719
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K082590. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE METER WAS RETURNED WITH THE FOLLOWING FINDINGS: THE LCD ON THE METER WAS CRACKED/BROKEN.

    Description of Event or Problem · 1

    THE LAY REPORTER / MOTHER CONTACTED LFS ON (B)(6) 2011, ALLEGING A DISPLAY ISSUE ON HER SON'S ONE TOUCH PING METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE REPORTER ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE MOTHER MENTIONED THAT PRIOR TO TESTING ON THE AFTERNOON OF (B)(6) 2011 SHE HAD NOTICED A COUPLE OF DAYS BACK THAT THERE WAS AN ISSUE WITH THE METER DISPLAY. SHE CLAIMS IT WAS TWO SMALL MARKS ON THE DISPLAY. AT THAT TIME SHE THOUGHT ABOUT CONTACTING LFS, SINCE SHE KNEW SOMETIME SOON THAT SHE WOULD NOT BE ABLE TO READ THE DISPLAY; HOWEVER, NOT GOT A CHANCE TO CONTACT LFS. EARLIER ON (B)(6) 2011 HER SON WAS ABLE TO TEST; HOWEVER, SHE DOES NOT RECALL THE READING. HE DID NOT EXHIBIT ANY SYMPTOMS TO THE MORNING RESULT AND TOOK HIS INSULIN ACCORDINGLY. AT AROUND 1:00PM, HE NOTICED THE STAIN ON HIS METER WAS SURROUNDING THE DISPLAY AREA AND HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE. THERE WERE 2 BIG BLUE MARK AREAS ON THE ENTIRE DISPLAY. APPROXIMATELY 3 HOURS LATER, HE FELT BAD. MOTHER WAS UNABLE TO DESCRIBE THE SYMPTOMS AND ADVISED HIM TO TAKE HIS INSULIN, SINCE HE DID NOT TAKE HIS INSULIN AT 1:00PM WHEN HE WAS UNABLE TO TEST AT ALL THAT AFTERNOON. HE DID NOT SEEK ANY FURTHER MEDICAL TREATMENT OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. MOTHER DID NOT TAKE HIM TO THE HOSPITAL. SHE CLAIMED AFTER HE TOOK HIS USUAL DOSAGE OF INSULIN HE FELT BETTER. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THE PRODUCT WAS REPLACED. 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 PATIENT TOOK HIS USUAL DOSAGE OF MEDICATION AND FELT BETTER AFTER TAKING THE INSULIN. THE REPORTER DENIED THAT THE PATIENT SOUGHT ANY FURTHER MEDICAL TREATMENT. BASED ON THE INITIAL CALL AND SPEAKING TO THE REPORTER, THERE IS NO EVIDENCE OF MISUSE OF THE PRODUCT. THE COMPLAINT IS BEING REPORTED SINCE THERE WAS AN ISSUE WITH OF THE SUBJECT METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR