BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1871754 · Received October 15, 2010

    Report

    Report Number
    2939301-2010-09133
    Event Type
    Injury
    Date Received
    October 15, 2010
    Report Date
    September 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE LANCET HOLDER ON THE ONETOUCH® LANCING DEVICE IS DAMAGED. THE PATIENT'S DIABETES IS MANAGED WITH METFORMIN ORAL MEDICATION AND 50 UNITS OF R INSULIN IN THE MORNING AND 42 UNITS OF R INSULIN DURING AFTERNOON/NIGHT TIME. ACCORDING TO THE PATIENT, THE LANCING DEVICE ISSUE BEGAN 2 MONTHS AGO. ONE WEEK AFTER THE LANCING DEVICE ISSUE BEGAN, THE PATIENT TOOK HER USUAL DIABETES MEDICAL AND REPORTEDLY DEVELOPED SYMPTOMS DESCRIBED AS "SWEATY AND FAST HEART RATE." IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. THE PATIENT OBTAINED READINGS IN THE RANGE OF "200-300 MG/DL" ON HER SISTER'S METER AT SOME POINT. AROUND (B)(6) 2010, THE PATIENT WENT FOR A DOCTOR'S OFFICE VISIT WHERE HIS INSULIN REGIMEN WAS INCREASED TO 56 UNITS OF R INSULIN IN THE MORNING AND 48 UNITS OF R INSULIN IN THE AFTERNOON/NIGHT TIME. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE LANCING DEVICE ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening