BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE SMART SYSTEM GLUCOSE CONTROL LOW

    MDR report key: 353371 · Received September 26, 2001

    Report

    Report Number
    MW1022922
    Event Type
    Malfunction
    Date Received
    September 26, 2001
    Date of Event
    September 14, 2001
    Report Date
    September 14, 2001
    Manufacturer
    *
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RPTR RECEIVED 2 UNITS OF PRESTIGE SMART SYSTEM GLUCOSE CONTROL LOW WITH NDC PRINTED AS 56151-563-01. HOWEVER, SUCH NDC IS NOT CONSISTENT WITH THE NDC CITED IN 2001 RED BOOK. RPTR CONTACTED CUSTOMER SUPPORT OF HOME DIAGNOSTICS, INC AND CONFIRMED THAT THE LOW SHOULD CARRY NCD 56151-561-1. APPARENTLY, THERE WAS A DISCREPANCY ON THE NCD PRINTED ON THE PACKAGE. ADVISED THAT REPLACEMENTS OF SUCH MAY BE ARRANGED, IF NECESSARY. THE BOTTLE WITHIN THE PACKAGE IS ACTUALLY LABELLED CORRESPONDINGLY AS LOW. NO ACTUAL DISPENSING TO PT TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43503 PRESTIGE SMART SYSTEM GLUCOSE CONTROL LOW * CFR * * CONL-017

    Patients

    Seq Age Sex Outcome Treatment
    1 *