BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEWISE BLOOD PRESSURE MONITOR

    MDR report key: 557089 · Received October 20, 2004

    Report

    Report Number
    MW1033740
    Event Type
    Injury
    Date Received
    October 20, 2004
    Report Date
    October 20, 2004
    Manufacturer
    RADIOSHACK
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT PURCHASED A LIFEWISE BLOOD PRESSURE MONITOR FROM A STORE IN 2004. IT CLAIMS ACCURACY WITHIN 3MM OF MERCURY. AFTER RELYING ON THIS DEVICE TO PROPERLY MONITOR THEIR BLOOD PRESSURE, THEY LEARNED THAT IT HAS BEEN AT LEAST 10- 15MM/HG OFF IN ITS RELIABILITY. DR SAID PT SHOULD HAVE BEEN ON HIGH BLOOD PRESSURE MEDICINE SINCE THEY STARTED USING THIS DEVICE AND THEY ARE AT LEAST 5 MONTHS LATE IN BEING TREATED. THEY THINK THIS DEVICE SHOULD BE WITHDRAWN FORM THE MARKET AND STORE SHOULD BE HELD ACCOUNTABLE FOR MARKETING AND SELLING SOMETHING THAT COULD PUT LIVES IN DANGER.

    Description of Event or Problem · 1

    PT PURCHASED A LIFEWISE BLOOD PRESSURE MONITOR FROM A STORE IN 2004. IT CLAIMS ACCURACY WITHIN 3 MM OF MERCURY. AFTER RELYING ON THIS DEVICE TO PROPERLY MONITOR THEIR BLOOD PRESSURE, THEY LEARNED THAT IS HAS BEEN AT LEAST 10-15 MM/HG OFF IN ITS RELIABILITY. DR. SAID PT SHOULD HAVE BEEN ON HIGH BLOOD PRESSURE MEDICINE SINCE THEY STARTED USING THIS DEVICE AND THEY ARE AT LEAST 5 MONTHS LATE IN BEING TREATED. THEY THINK THIS DEVICE SHOULD BE WITHDRAWN FROM THE MARKET AND STORE SHOULD BE HELD ACCOUNTABLE FOR MARKETING AND SELLING SOMETHING THAT COULD PUT LIVES IN DANGER. THE PRODUCT DESCRIBED IN THE MEDICAL DEVICE REPORT IS AN ARM-CUFF BLOOD PRESSURE MONITOR, CATALOG NUMBER 63-1514. THE DEVICE IS MANUFACTURED BY HEALTH AND LIFE CO. (H&L), LTD. THE MANUFACTURER'S MODEL NUMBER IS HL888RA, MARKETED UNDER PRE-MARKET MOTIFICATION K030498. FACILITY'S 63-1514 IS BEING MARKETED UNDER PRE-MARKET NOTIFICATION K031835, WHICH INCORPORATES BY REFERENCE ALL OF THE INFO CONTAINED IN H&L'S PRE-MARKET NOTIFICATION. FACILITY BEGAN IMPORTING IN 2003. THE PRODUCT'S PROCUREMENT STATUS WAS CHANGE FROM "ACTIVE" TO "STOP BUY" IN 2004. AS A RESULT FACILITY IS NO LONGER IMPORTING ADDITIONAL QUANTITIES OF THE ARM-CUFF BLOOD PRESSURE MONITORS. FACILITY SALES RECORDS INDICATE 18,959 OF THESE UNITS WERE SOLD BETWEEN 2003 AND 2005. FACILITY INVENTORY RECORDS INDICATE THERE ARE 12,457 UNITS REMAINING IN STORE AND DISTRIBUTION CENTER STOCK. FACILITY CUSTOMER CARE AND COMPLAINT RECORDS SHOW NO RECORD OF ANY COMPLAINTS CONCERNING THE BLOOD PRESSURE MONITOR READING LOWER THAN THE MANUFACTURERS STATED LEVEL OF ACCURACY. CUSTOMER CARE HAS RECEIVED MORE THAN TWENTY INQUIRIES CONCERNING THE 65-1514. MOST OF THESE INQUIRES REGARDED THE AVAILABILITY OF A LARGER SIZE CUFF - ONE IS AVAILABLE BY SPECIAL ORDER, BUT NOT IN OUR RETAIL STORES. FACILITY FORWARDED THE MEDICAL DEVICE REPORT TO H&L AND REQUESTED DATA CONCERNING ANY SIMILAR FAILURE REPORTS OF ITS HL888RA ARM-CUFF BLOOD PRESSURE MONITOR. NO UNITS HAVE BEEN RETURNED DUE TO ACCURACY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEWISE BLOOD PRESSURE MONITOR BLOOD PRESSURE MONITOR -ARM CUFF- DXN RADIOSHACK 63-1514 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention