BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 14366387 · Received May 11, 2022

    Report

    Report Number
    1119779-2022-00684
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 10, 2022
    Report Date
    June 28, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486076
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BD PHOENIX BD PHOENIX¿ PMIC/ID-107 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K020322, K021954, K023273, K023301, K024152, K030677, K031306, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, K131331. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUTION?: YES. D9: RETURNED TO MANUFACTURER ON: 14-APR-2022 H6: INVESTIGATION SUMMARY THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS EPIDERMIDIS WHEN USING PHOENIX PANEL PMIC/ID-107((B)(4)) BATCH NUMBER 1266643. THE CUSTOMER DID RETURN LAB REPORTS AND PANELS, HOWEVER DID NOT RETURN ISOLATES FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF THREE PANELS FROM THE COMPLAINT BATCH, 1 CUSTOMER RETURNED, WERE TESTED USING QC ISOLATES OF STAPHYLOCOCCUS AUREUS ((B)(6)) ON A PHOENIX INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. ADDITIONALLY, 2 RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING BD ISOLATES OF STAPHYLOCOCCUS AUREUS (7146) ON A PHOENIX INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION, ALL PANELS IDENTIFIED CORRECTLY AS STAPHYLOCOCCUS AUREUS. THIS COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX¿ PMIC/ID-107, ERRONEOUS RESULTS WERE OBTAINED. S. AUREUS WAS INCORRECTLY IDENTIFIED AS S. EPIDERMIDIS. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) : (B)(6) 2022 20:11:39 (GMT) HOW OLD ARE THE ORGANISMS UPON PREPARATION OF INOCULUM? 18-24 HRS. PLEASE PROVIDE THE MANUFACTURER AND TYPE OF MEDIA CULTURES ARE BEING SET UP FROM? REMEL BAP. WAS CULTURE PURITY CONFIRMED? YES. DO YOU USE AN AP FOR SETUP OR DO YOU SET UP PANELS MANUALLY? AP. WHAT IS THE SN OF YOUR PHOENIX AP(IF APPLICABLE)? (B)(4). HAS AP CONTAMINATION BEEN RULED OUT? YES. WHAT IS THE INOCULUM DENSITY USED? 0.5. WHEN WAS YOUR PHOENIXSPEC LAST CALIBRATED? HAVE YOU TRIED RECALIBRATING? 02/22, NO. ARE YOUR CALIBRATORS IN DATE? YES. HOW ARE THE PANELS STORED BEFORE USE? AMBIENT, IN SEALED FOIL. HOW LONG BEFORE USE ARE THEY TAKEN OUT OF FOIL PACKAGING? <2 HOURS. HOW ARE ID BROTHS STORED BEFORE USE? AMBIENT, DARK. HOW LONG DO INOCULATED BROTHS SIT PRIOR TO PANEL INOCULATION? <1.5 HOURS. HOW LONG AFTER PANEL INOCULATION ARE PANELS LOADED ONTO INSTRUMENT? <30 MIN. WHAT IS THE SERIAL NUMBER OF YOUR PHOENIX? (B)(4). WHAT IS THE SOFTWARE VERSION OF YOUR PHOENIX? 1.1.80.0/V6.51A. WHAT IS THE SOFTWARE VERSION AND PUD OF YOUR EPICENTER? V7.22A SR 2 UPDATE DISK VERSION V6.51A. WAS THE MIS ID'S SPECIMEN A PATIENT SPECIMEN OR A QC PANEL? PATIENT. WERE ANY PATIENT RESULTS AFFECTED DUE TO THE MIS ID? JUST A DELAY IN RESULT REPORTING. WHAT IS THE SEQUENCE NUMBER OF THE AFFECTED PANEL? 426072039890, 426072039871. *HAS QC PASSED FOR THIS PANEL LOT NUMBER? YES. ARE YOU ABLE TO RETURN THE ISOLATE FOR INVESTIGATION? YES. ARE YOU ABLE TO SEND IN 3 PANELS/TUBES FROM LOTS LISTED ABOVE FOR QUALITY INVESTIGATION IF A PREPAID RETURN SHIPPING LABEL WAS SENT TO YOU? I¿M ABLE TO SEND IN ONE PANEL ONLY. (B)(6) : (B)(6) 2022, 20:10:22 (GMT) WHAT WAS THE CONDITION OF THE SHIPMENT UPON RECEIPT? ACCEPTABLE. HOW WAS THE PRODUCT STORED? AMBIENT. HOW MUCH PRODUCT WAS RECEIVED? 12 BOXES. HOW MUCH PRODUCT WAS AFFECTED? 2 PANELS, 2 ID BROTHS, 2 AST BROTHS. DOES THE PRODUCT SHIP DIRECT FROM BD OR FROM A DISTRIBUTOR? DIRECT FROM BD. IF YOUR COMPLAINT IS CONFIRMED, DO YOU PREFER REPLACEMENTS? REIMBURSEMENT TO OUR ACCOUNT. PLEASE ATTACH ANY SPECIMEN (OR QC) LAB REPORTS IN A REPLY TO THIS EMAIL. HOW WAS MIS-ID DETERMINED? WHAT ALTERNATE METHOD OR CONFIRMATORY TESTING WAS USED? MALDI-TOF. WERE THERE ANY MIC RESULTS THAT WERE INACCURATE? NO. PLEASE PROVIDE THE FOLLOWING LOT NUMBERS AND STORAGE CONDITIONS: PANEL: 1266643 AMBIENT. ID BROTH LOT NUMBER: 1335976. AP ID BROTH LOT NUMBER:1175263. AST BROTH: 2011043. AST INDICATOR/AST-S INDICATOR: 1215417. (B)(6) : (B)(6) 2022 16:24:56 (GMT). REVIEWED, PENDING CUSTOMER FOLLOW UP. IT WAS REPORTED BY THE CUSTOMER THAT INCORRECT ORGANISM IDENTIFICATION ON 448607 LOT: 1266643. (B)(6) : (B)(6) 2022 12:57:01 (GMT): SUBJECT: EMAIL (B)(6) 2022, 8:14:11 AM USER: (B)(6) CREATED ON: (B)(6) 2022 12:14:11 CALL ACTIVITY COMMENT: NULL. (B)(6) : (B)(6) 2022 12:52:42 (GMT): CUSTOMER PROBLEM: CUSTOMER REPORTS INCORRECT ORGANISM IDENTIFICATION ON 448607 LOT: 1266643. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER REPORTS PHOENIX PANELS IDENTIFIED THE ORGANISM AS STAPHYLOCOCCUS EPIDERMIDIS BUT THE TRUE IDENTIFICATION IS STAPHYLOCOCCUS AUREUS. NEXT STEPS (IF NECESSARY): FOLLOW UP INFORMATION AND MIS-ID SPECIFIC INFORMATION. RESOLUTION ACHIEVED (Y/N)?: NO. QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 PANEL OF FOLLOW UP. SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): FOLLOW UP. IF IT IS A DISTRIBUTOR ¿ WHO IS IT? FOLLOW UP. PHOTOS OR RETURNS REQUESTED? FOLLOW UP. REPLACEMENTS OR CREDIT REQUESTED: FOLLOW UP. FOLLOW UP REQUIRED (Y/N)? YES. INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): CLINICAL. IS A LETTER SIGNED BY QUALITY REQUIRED (Y/N)?: NP. REVIEWED SMAX CASE HISTORY: YES. CUSTOMER HAS A LENGTHY HISTORY OF MIS-ID INVESTIGATIONS GOING BACK TO (B)(6) 2021. HELP LIGHTNING ATTEMPT: NO. HELP LIGHTNING SUCCESS: NO. (B)(4) : (B)(6) 2022 12:37:06 (GMT): CUSTOMER REPORTS INCORRECT ORGANISM IDENTIFICATION ON 448607 LOT: 1266643.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX¿ PMIC/ID-107, ERRONEOUS RESULTS WERE OBTAINED. S. AUREUS WAS INCORRECTLY IDENTIFIED AS S. EPIDERMIDIS. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) : (B)(6)2022 20:11:39 (GMT) *HOW OLD ARE THE ORGANISMS UPON PREPARATION OF INOCULUM? 18-24 HRS *PLEASE PROVIDE THE MANUFACTURER AND TYPE OF MEDIA CULTURES ARE BEING SET UP FROM? REMEL BAP *WAS CULTURE PURITY CONFIRMED? YES *DO YOU USE AN AP FOR SETUP OR DO YOU SET UP PANELS MANUALLY? AP *WHAT IS THE SN OF YOUR PHOENIX AP(IF APPLICABLE)? (B)(6) *HAS AP CONTAMINATION BEEN RULED OUT? YES *WHAT IS THE INOCULUM DENSITY USED? 0.5 *WHEN WAS YOUR PHOENIXSPEC LAST CALIBRATED? HAVE YOU TRIED RECALIBRATING?(B)(6), NO *ARE YOUR CALIBRATORS IN DATE? YES *HOW ARE THE PANELS STORED BEFORE USE? AMBIENT, IN SEALED FOIL *HOW LONG BEFORE USE ARE THEY TAKEN OUT OF FOIL PACKAGING? <2 HOURS *HOW ARE ID BROTHS STORED BEFORE USE? AMBIENT, DARK *HOW LONG DO INOCULATED BROTHS SIT PRIOR TO PANEL INOCULATION? <1.5 HOURS *HOW LONG AFTER PANEL INOCULATION ARE PANELS LOADED ONTO INSTRUMENT? <30 MIN *WHAT IS THE SERIAL NUMBER OF YOUR PHOENIX? (B)(6) *WHAT IS THE SOFTWARE VERSION OF YOUR PHOENIX? 1.1.80.0/V6.51A *WHAT IS THE SOFTWARE VERSION AND PUD OF YOUR EPICENTER? V7.22A SR 2 UPDATE DISK VERSION V6.51A *WAS THE MIS ID'S SPECIMEN A PATIENT SPECIMEN OR A QC PANEL? PATIENT *WERE ANY PATIENT RESULTS AFFECTED DUE TO THE MIS ID? JUST A DELAY IN RESULT REPORTING *WHAT IS THE SEQUENCE NUMBER OF THE AFFECTED PANEL? (B)(4), (B)(4) *HAS QC PASSED FOR THIS PANEL LOT NUMBER? YES *ARE YOU ABLE TO RETURN THE ISOLATE FOR INVESTIGATION? YES *ARE YOU ABLE TO SEND IN 3 PANELS/TUBES FROM LOTS LISTED ABOVE FOR QUALITY INVESTIGATION IF A PREPAID RETURN SHIPPING LABEL WAS SENT TO YOU? I¿M ABLE TO SEND IN ONE PANEL ONLY. (B)(6): (B)(6)2022 20:10:22 (GMT) WHAT WAS THE CONDITION OF THE SHIPMENT UPON RECEIPT? ACCEPTABLE HOW WAS THE PRODUCT STORED? AMBIENT HOW MUCH PRODUCT WAS RECEIVED? 12 BOXES HOW MUCH PRODUCT WAS AFFECTED? 2 PANELS, 2 ID BROTHS, 2 AST BROTHS DOES THE PRODUCT SHIP DIRECT FROM BD OR FROM A DISTRIBUTOR? DIRECT FROM BD IF YOUR COMPLAINT IS CONFIRMED, DO YOU PREFER REPLACEMENTS? REIMBURSEMENT TO OUR ACCOUNT **PLEASE ATTACH ANY SPECIMEN (OR QC) LAB REPORTS IN A REPLY TO THIS EMAIL. *HOW WAS MIS-ID DETERMINED? WHAT ALTERNATE METHOD OR CONFIRMATORY TESTING WAS USED? MALDI-TOF *WERE THERE ANY MIC RESULTS THAT WERE INACCURATE? NO *PLEASE PROVIDE THE FOLLOWING LOT NUMBERS AND STORAGE CONDITIONS: -PANEL: 1266643 AMBIENT -ID BROTH LOT NUMBER: 1335976 -AP ID BROTH LOT NUMBER:1175263 -AST BROTH: 2011043 -AST INDICATOR/AST-S INDICATOR: 1215417 (B)(6) : (B)(6)2022 16:24:56 (GMT) REVIEWED, PENDING CUSTOMER FOLLOW UP IT WAS REPORTED BY THE CUSTOMER THAT INCORRECT ORGANISM IDENTIFICATION ON 448607 LOT: 1266643. (B)(6) : (B)(6) 2022 12:57:01 (GMT) SUBJECT: EMAIL (B)(6)2022, 8:14:11 AM USER: (B)(6) CREATED ON: (B)(6)2022 12:14:11 CALL ACTIVITY COMMENT: NULL (B)(6): (B)(6) 2022 12:52:42 (GMT) CUSTOMER PROBLEM: CUSTOMER REPORTS INCORRECT ORGANISM IDENTIFICATION ON 448607 LOT: 1266643 STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: OPENED A COMPLAINT. CUSTOMER REPORTS PHOENIX PANELS IDENTIFIED THE ORGANISM AS STAPHYLOCOCCUS EPIDERMIDIS BUT THE TRUE IDENTIFICATION IS STAPHYLOCOCCUS AUREUS. NEXT STEPS (IF NECESSARY): FOLLOW UP INFORMATION AND MIS-ID SPECIFIC INFORMATION. RESOLUTION ACHIEVED (Y/N)?: NO QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 PANEL OF FOLLOW UP SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): FOLLOW UP IF IT IS A DISTRIBUTOR ¿ WHO IS IT? FOLLOW UP PHOTOS OR RETURNS REQUESTED? FOLLOW UP REPLACEMENTS OR CREDIT REQUESTED: FOLLOW UP FOLLOW UP REQUIRED (Y/N)? YES INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): CLINICAL IS A LETTER SIGNED BY QUALITY REQUIRED (Y/N)?: NP REVIEWED SMAX CASE HISTORY: YES. CUSTOMER HAS A LENGTHY HISTORY OF MIS-ID INVESTIGATIONS GOING BACK TO 6/2021 HELP LIGHTNING ATTEMPT: NO HELP LIGHTNING SUCCESS: NO (B)(6): (B)(6)2022 12:37:06 (GMT) CUSTOMER REPORTS INCORRECT ORGANISM IDENTIFICATION ON 448607 LOT: 1266643

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954672 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 448607 1266643 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown