BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1695208 · Received May 20, 2010

    Report

    Report Number
    1823260-2010-03089
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Date of Event
    March 30, 2010
    Report Date
    May 25, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT A LAUNCHER 7F (EBU3.75) WAS USED DURING THIS PROCEDURE. MEDTRONIC WAS MADE AWARE OF THIS INFO ON 05/05/2010. THREE ENDEAVOR RESOLUTE RX DRUG-ELUTING STENTS (2.25MM X 14MM, 2.50MM X 14MM, AND 3.50MM X 15MM) (REF MFR REPORT# 2953200-2010-00674, 2953200-2010-00675, 2953200-2010-00676) WERE INSERTED INTO A PT FOR TREATMENT OF A LEFT MAIN AND LAD. A 3.50 X 20 MM SPRINTER LEGEND RX BALLOON DILATATION CATHETER (MFR REPORT#: 2953200-2010-00863), A 4.00MM X 12MM NC SPRINTER RX BALLOON DILATATION CATHETER (MFR REPORT#: 2953200-2010-00864) LESION MORPHOLOGY WAS REPORTED AS SMALL CALCIFIED DIFFUSELY DISEASED CORONARY ARTERIES WITH SIGNIFICANT STENOSIS OF THE LEFT MAIN, PROXIMAL CX AND LAD/ORIGIN DIAGONAL. THE LAD/DIAGONAL WERE DILATED WITH GOBA (BALLOON ONLY). FOLLOWING PRE-DILATATION THE 2.25MM DIAMETER X 14MM LENGTH STENT WAS IMPLANTED AT THE PROXIMAL CX. STENTS WERE IMPLANTED IN THE LEFT MAIN AND ORIGIN LAD, FOLLOWED BY POST DILATATION TO 4 MM. THERE WAS A GOOD ANGIOGRAPHIC RESULT. THE POST OPERATIVE COURSE REPORTED EPISODES OF CHEST PAIN, TROPONIN RISE, HEART FAILURE, AND COLLAPSE AFTER 7 DAYS. IT IS REPORTED THAT THE PT HAD AN EMERGENCY RE-CATHETERIZATION. THE MAIN ARTERIES WERE OPEN BUT NO FILLING OF THE SMALL SIDE BRANCHES WERE OBSERVED. IT IS REPORTED THAT THE PT DIED A WEEK LATER. AN AUTOPSY WAS PERFORMED WHICH SHOWED EXTENSIVE MYOCARDIAL DAMAGE. DEVICES WERE NOT RECEIVED FOR EVAL. SEPARATE MDR'S HAVE BEEN FILED FOR EACH PRODUCT USED IN THIS CASE THEY ARE: ENDEAVOR RESOLUTE-REPORT#2953200-2010-00674 (B) (4), ENDEAVOR RESOLUTE-REPORT#2953200-2010-00675 (B) (4), ENDEAVOR RESOLUTE-REPORT#2953200-2010-00676 , (B) (4), SPRINTER LEGEND RX-REPORT#2953200-2010-00863 (B) (4), NC SPRINTER RX-REPORT#2953200-2010-00864 (B) (4), ZINGER LIGHT SUPPORT 180CM-REPORT# 1220452201000025 (B) (4).

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT A NEONATE RECEIVED THE RESULT OF 29 MG/DL ON THE INFORM SYSTEM COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 4 MG/DL OBTAINED ON A LAB SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551100

    Patients

    Seq Age Sex Outcome Treatment
    1 001 MO