BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1828381 · Received September 8, 2010

    Report

    Report Number
    2939301-2010-07672
    Event Type
    Injury
    Date Received
    September 8, 2010
    Report Date
    August 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 510 (K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE PATIENT ALLEGING AN "ERROR 2" ISSUE WITH A ONE TOUCH PING METER. THE REPORTER WAS NOT WILLING TO ANSWER QUESTIONS OR PROVIDE INFORMATION TO THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THE COMPLAINT BASED ON THE FOLLOWING INFORMATION: IT IS UNKNOWN WHAT DATE/TIME THE ALLEGED ISSUE BEGAN. THE CSR NOTED THAT THE REPORTED ERROR OCCURRED 8 TIMES. DUE TO THE ALLEGED ISSUE, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED UNSPECIFIED SYMPTOM(S) OF "HYPOGLYCEMIA." THE REPORTER DENIED THAT THE PATIENT RECEIVED TREATMENT BECAUSE OF THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER AND TEST STRIPS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED "HYPOGLYCEMIA" AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3020385

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Life Threatening