BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK® 2 GN ID TEST KIT

    MDR report key: 8639951 · Received May 24, 2019

    Report

    Report Number
    1950204-2019-00154
    Event Type
    Injury
    Date Received
    May 24, 2019
    Report Date
    July 18, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF INJURIES FOR THREE EMPLOYEES, IN ASSOCIATION WITH THE USE OF THE VITEK® 2 GN ID TEST KIT (REFERENCE 21341). THE CUSTOMER REPORTED THAT EMPLOYEES COMPLAIN OF PAIN FROM OPENING THE VITEK 2 CARD POUCHES AND HAVE INCURRED SICK LEAVES DUE TO THE FREQUENT OPENING OF THE VITEK 2 CARD POUCHES (NO MATTER THE CARD TYPE). THE CUSTOMER STATED THAT APPROXIMATELY 240 VITEK 2 CARD POUCHES ARE OPENED PER DAY; SOME DAYS UP TO 300 CARDS ARE OPENED AND USED. THE CUSTOMER CLAIMS THAT, AS A CONSEQUENCE, THREE (3) COWORKERS HAVE BEEN IMPACTED. THE EMPLOYEE ASSOCIATED WITH THIS MEDWATCH REPORT (1950204-2019-00154) REPORTEDLY DEVELOPED INFLAMMATION OF THE TENDON SHEATH. THIS PERSON WAS ON SICK LEAVE FOR FIVE (5) WEEKS AND HAD TO WEAR SPLINTS FOR THREE (3) WEEKS TO IMMOBILIZE THE HAND. IT WASN'T RECALLED IF MEDICATION WERE PRESCRIBED. BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. CUSTOMERS HAVE INDICATED THAT SOME POUCHES WERE EASIER TO OPEN THAN OTHERS, AND PHOTOS OF THE 'DIFFICULT' AND 'EASIER' POUCHES HAVE BEEN RECEIVED. - A "DIFFICULT" POUCH WAS FROM AST-P655 LOT 8050804103. THIS POUCH WAS MANUFACTURED ON MANUFACTURING POUCHER 4. THE POUCH HAS THE THREE-RIB SIDE SEAL AND THE SAWTOOTH TEAR NOTCH PATTERN. THE SAWTOOTH PATTERN PROVIDES THE USER MULTIPLE LOCATIONS TO TEAR THE POUCH OPEN. THIS PATTERN HAS BEEN USED WITH NO MODIFICATIONS SINCE AUGUST 2016. - A "EASIER" POUCH WAS FROM AST-P654 LOT 8040935203. THIS POUCH WAS MANUFACTURED ON POUCHER 7. THE POUCH HAS THE TWO-RIB SIDE SEAL AND A SINGLE TEAR NOTCH. HAVING FEWER RIBS MEANS THERE IS LESS SEALED MATERIAL THROUGH WHICH TO TEAR, MAKING THE POUCH EASIER TO OPEN. IN ADDITION TO FEWER RIBS, THE TEAR NOTCH ITSELF CHANGED FROM A SAWTOOTH PATTERN TO A SINGLE TEAR NOTCH. THE SAWTOOTH TEAR NOTCH DESIGN IS A ZIG-ZAG PATTERN AT THE EDGE OF THE SIDE SEAL, WHEREAS THE SINGLE TEAR NOTCH DESIGN IS A NOTCH THAT IS CUT INTO THE SIDE SEAL. THE SINGLE TEAR NOTCH ESSENTIALLY STARTS THE TEARING PROCESS OF OPENING A POUCH. TO DATE, POUCHER 5 AND POUCHER 6 HAVE RECEIVED THE UPGRADES TO THE SIDE SEAL RIB COUNT AND THE TEAR NOTCH. VALIDATION ACTIVITIES ARE COMPLETE FOR THESE POUCHERS, AND THEY ARE BEING USED TO MANUFACTURE DISTRIBUTED LOTS. POUCHER 7, THE MOST RECENT POUCHER, HAS ALWAYS HAD THE SINGLE TEAR NOTCH AND THE TWO-RIB SIDE SEAL. CURRENT PROJECTIONS INDICATE THAT VALIDATION OF POUCHERS 1 - 4 WILL BE COMPLETE BY OCTOBER 2019. A CUSTOMER COMPLAINT QUERY WAS PERFORMED FOR THE PERIOD 01JAN2014 TO 31MAY2019 FOR "DIFFICULT TO OPEN POUCHES" AND/OR "INJURIES RELATED TO POUCHES". THE WHITE POUCH WITH THE SAWTOOTH TEAR NOTCH DESIGN WAS IMPLEMENTED IN AUGUST 2016. THE QUERY INCLUDED TWO YEARS PRIOR TO THE WHITE POUCH IMPLEMENTATION TO IDENTIFY IF THERE WERE COMPLAINTS RELATED TO DIFFICULTY OPENING POUCHES WITH THE ORIGINAL SILVER POUCH WITH A SINGLE TEAR NOTCH DESIGN. THE REPORT SHOWED NO REPORTED COMPLAINTS RELATED TO THE SILVER POUCH. IN RESPONSE TO FOUR (4) CUSTOMER COMPLAINTS REGARDING DIFFICULTY OPENING WHITE POUCHES IN 2017 AND 2018, A DECISION TO MOVE FROM THE SAWTOOTH TEAR NOTCH DESIGN TO A SINGLE TEAR NOTCH DESIGN WAS ALREADY BEING IMPLEMENTED PRIOR TO RECEIVING THE (B)(6) COMPLAINTS IN (B)(6) 2019 RELATED TO CUSTOMER INJURY. THIS IS THE REASON POUCHER 7 HAD THE SINGLE TEAR NOTCH DESIGN WHEN IT WAS INITIALLY INSTALLED AND THEN VALIDATED IN (B)(6) 2018. AS NO CUSTOMER COMPLAINTS RELATING TO DIFFICULTY OPENING POUCHES AND/OR INJURIES FROM OPENING POUCHES HAD BEEN RECEIVED FOR THE SILVER POUCH, RAW MATERIAL COMPONENTS WERE REVIEWED COMPARING THE SILVER POUCH TO THE WHITE POUCH. THE RAW MATERIAL COMPONENTS COMPARISON OF THE SILVER POUCH TO THE WHITE POUCH SHOW THAT THERE WERE TWO (2) COMPONENT CHANGES WHEN THE WHITE POUCH WAS APPROVED. HOWEVER, THE OVERALL THICKNESS OF THE MATERIAL REMAINED VIRTUALLY THE SAME. ROOT CAUSE WAS DETERMINED TO BE THE SAWTOOTH DESIGN OF THE TEAR NOTCH COMBINED WITH THE 3-RIB SIDE SEAL. ADDITIONALLY, FEEDBACK HAS BEEN PROVIDED BY END USERS STATING THAT THE TWO-RIB SIDE SEAL WITH A SINGLE TEAR NOTCH DESIGN IS EASIER TO OPEN COMPARED TO THE SAWTOOTH TEAR NOTCH DESIGN WITH THE THREE-RIB SIDE SEAL. THE RISK ASSOCIATED WITH DIFFICULTY OPENING VITEK 2 POUCHES IS A REPETITIVE STRESS INJURY. THIS IS IDENTIFIED IN THE VITEK 2 SYSTEMS HAZARD DEFINITION AND IMPACT DOCUMENT. THE UPGRADES INSTALLED TO THE POUCHING EQUIPMENT TO IMPLEMENT A SINGLE TEAR NOTCH AND A TWO-RIB SIDE SEAL WILL MAKE THE POUCH EASIER TO OPEN. HOWEVER, THE POTENTIAL FOR REPETITIVE STRESS INJURY STILL EXISTS AND WILL REMAIN IN THE VITEK 2 SYSTEMS HAZARD DEFINITION AND IMPACT DOCUMENT. THE INVESTIGATION CONCLUDED THAT ROOT CAUSE HAS BEEN IDENTIFIED, AND THAT MITIGATING ACTIONS ARE IN PROGRESS TO BE COMPLETED BY OCTOBER 2019. NOTE: AT THE TIME OF THIS REPORT, ONLY (B)(6) HAS REPORTED EVENTS OF INJURY RELATED TO THE PROCESS OF OPENING VITEK 2 CARD POUCHES. NO OTHER COUNTRIES/CUSTOMERS, EVEN THOSE WHOSE CARD VOLUME IS HIGHER, HAVE REPORTED STRESS INJURIES RELATED TO THE CARD POUCHES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF INJURIES FOR THREE EMPLOYEES, IN ASSOCIATION WITH THE USE OF THE VITEK® 2 GN ID TEST KIT (REFERENCE 21341). THE LOT NUMBERS FOR THE VITEK 2 CARDS ASSOCIATED WITH THIS REPORT WERE NOT PROVIDED. THE CUSTOMER HAS REPORTED THAT EMPLOYEES COMPLAIN OF PAIN FROM OPENING THE VITEK 2 CARD POUCHES AND HAVE INCURRED SICK LEAVES DUE TO THE FREQUENT OPENING OF THE VITEK 2 CARD POUCHES (NO MATTER THE CARD TYPE). THE CUSTOMER STATED THAT APPROXIMATELY 240 VITEK 2 CARD POUCHES ARE OPENED PER DAY; SOME DAYS UP TO 300 CARDS ARE OPENED AND USED. THE CUSTOMER INDICATED THAT CONSIDERABLY MORE STRENGTH IS NECESSARY THAN WITH THE PREVIOUS FOIL CARD POUCHES. IN ADDITION THE NOTCHES ARE OFTEN NOT BIG ENOUGH, SO EVEN MORE STRENGTH IS NEEDED TO OPEN THE CARD POUCHES. THE CUSTOMER ALSO STATED THE TEAR OF THE POUCH IS OFTEN NOT PARALLEL TO THE EDGE. THEREFORE, ONLY ONE CORNER OF THE POUCH IS OPEN AND THIS OFTEN HAPPENS ON THE OTHER CORNER AS WELL. CONSEQUENTLY TWO CORNERS ARE GONE, BUT ONE STILL CANNOT TAKE THE CARD FROM THE POUCH. THE CUSTOMER CLAIMS THAT, AS A CONSEQUENCE, THREE (3) COWORKERS HAVE BEEN IMPACTED. THE EMPLOYEE ASSOCIATED WITH THIS MEDWATCH REPORT REPORTEDLY DEVELOPED INFLAMMATION OF THE TENDON SHEATH. THIS PERSON WAS ON SICK LEAVE FOR FIVE (5) WEEKS AND HAD TO WEAR SPLINTS FOR THREE (3) WEEKS TO IMMOBILIZE THE HAND. IT WASN'T RECALLED IF PILLS/MEDICINE WERE PRESCRIBED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: THE DETAIL OF THE OTHER TWO LABORATORY PERSONNEL ARE DOCUMENTED IN MEDWATCH REPORTS 1950204-2019-00155 AND 1950204-2019-00156.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434520 VITEK® 2 GN ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX, INC. 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other