BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1832519 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07799
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 2, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF BASAL/BOLUS INFUSOR RUPTURED DURING FILLING. THE DEVICE WAS BEING FILLED WITH FENTANYL CITRATE AND NORMAL SALINE. AFTER THE DEVICE WAS FILLED WITH 90ML, THE RESERVOIR RUPTURED. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE LAY REPORTER (MOTHER) CONTACTED LFS ON (B)(6) 2010 ALLEGING INACCURATE HIGH READING ON HER SON'S ONE TOUCH PING METER. THE REPORTER MENTIONED THAT SHE TESTED HER SON'S BLOOD GLUCOSE ON (B)(6) 2010 AND OBTAINED A RESULT OF 102 MG/DL. SHE TESTED HIM AGAIN AN HOUR LATER BECAUSE HE FELT SHAKY AND HUNGRY AND OBTAINED A 102 MG/DL AGAIN. SHE THEN RETESTED HIM AND OBTAINED A 66 MG/DL. SHE TREATED HIM WITH A JUICE BOX TO RAISE HIS BLOOD GLUCOSE. THE REPORTER DID NOT SEEK ANY FURTHER MEDICAL ATTENTION FOR THE PATIENT OR CONTACT THE PATIENT'S PHYSICIAN FOR ASSISTANCE. REPORTER MENTIONED THAT FOR THE PAST WEEK, SHE HAS NOTICED HER SON'S BLOOD GLUCOSE RESULTS BEING THE SAME VALUE (EXAMPLE: SHE TESTED HIM ON AN UNSPECIFIED DATE AND TIME THE WEEK PRIOR AND OBTAINED A 276 MG/DL AND THE FOLLOWING MORNING WHEN SHE TESTED HIM, SHE OBTAINED A 276 MG/DL AGAIN). A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT HER SON DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, AFTER THE METER HAD BEEN DISPLAYING ALLEGEDLY HIGH READINGS AND HAD TO TREAT HER SON WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3031255

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening| R