BD BACTEC¿ MGIT¿ 960 SYSTEM
Report
- Report Number
- 1119779-2022-00242
- Event Type
- Malfunction
- Date Received
- February 15, 2022
- Date of Event
- January 25, 2022
- Report Date
- July 1, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 00382904458706
- PMA / PMN Number
- K974883
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
CORRECTION; ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE FOLLOWING FIELD HAS BEEN UPDATED: B5 - EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE RUNNING SAMPLES ON BD BACTEC¿ MGIT¿ 960 SYSTEM FALSE POSITIVE RESULTS ARE OBTAINED, HOWEVER, THE CURVES READ DIFFERENTLY. GRAM-STAIN WAS PERFORMED WITH RESULTS RETURNING AS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED TO CLINICIANS. THERE WAS NO ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MANY OF THE TUBES GIVE A POSITIVE RESULT AT 35 DAYS, WHILE THE CURVES SHOW SOMETHING ELSE. 1. WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? GRAM STAINING. 2. WERE ANY ERRONEOUS RESULTS REPORTED TO THE HEALTHCARE PROVIDER BY LABORATORY PERSONNEL? NO. 3. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. 4. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO. 5. ENTRY DESCRIPTION STATES: "WHILE THE CURVES SHOW SOMETHING ELSE." -- WHAT DID THE CURVES SHOW? CURVES DO NOT SHOW GROWTH, CASE SOLVED (B)(4).
H.6 INVESTIGATION SUMMARY: THIS COMPLAINT ALLEGES A FALSE POSITIVE ON A MGIT 960 INSTRUMENT (P/N 445870, S/N (B)(6)). THE CUSTOMER CALLED IN TO REPORT THAT THEIR INSTRUMENT HAD MULTIPLE FALSE POSITIVE RESULTS. A FIELD SERVICE ENGINEER (FSE) ARRIVED ONSITE TO TROUBLESHOOT THE INSTRUMENT. THE FSE REPLACED THE INSTRUMENT CALIBRATORS AND TESTED THE INSTRUMENT. THE INSTRUMENT WAS RETURNED TO THE CUSTOMER IN WORKING ORDER. NO SAMPLES OR PARTS WERE RETURNED FOR THIS COMPLAINT AND THUS, RETURNED SAMPLE ANALYSIS CANNOT BE COMPLETED. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. ROOT CAUSE IS UNKNOWN AT THIS TIME. THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. COMPLAINT HISTORY FOR RESULTS WAS REVIEWED FOR THE MONTH OF JANUARY. THE UPPER CONTROL LIMIT WAS NOT BREACHED, AND TRENDS WERE NOT IDENTIFIED ASSOCIATED WITH THIS DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CORRECTIVE AND PREVENTATIVE ACTION (CAPA) IS NOT REQUIRED AS NO TRENDS WERE IDENTIFIED, AND THIS COMPLAINT IS UNCONFIRMED.
IT WAS REPORTED THAT WHILE RUNNING SAMPLES ON BD BACTEC¿ MGIT¿ 960 SYSTEM FALSE POSITIVE RESULTS ARE OBTAINED, HOWEVER, THE CURVES READ DIFFERENTLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: MANY OF THE TUBES GIVE A POSITIVE RESULT AT 35 DAYS, WHILE THE CURVES SHOW SOMETHING ELSE.
IT WAS REPORTED THAT WHILE RUNNING SAMPLES ON BD BACTEC¿ MGIT¿ 960 SYSTEM FALSE POSITIVE RESULTS ARE OBTAINED, HOWEVER, THE CURVES READ DIFFERENTLY. GRAM-STAIN WAS PERFORMED WITH RESULTS RETURNING AS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED TO CLINICIANS. THERE WAS NO ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MANY OF THE TUBES GIVE A POSITIVE RESULT AT 35 DAYS, WHILE THE CURVES SHOW SOMETHING ELSE. 1. WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? GRAM STAINING 2. WERE ANY ERRONEOUS RESULTS REPORTED TO THE HEALTHCARE PROVIDER BY LABORATORY PERSONNEL? NO. 3. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. 4. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO. 5. ENTRY DESCRIPTION STATES: "WHILE THE CURVES SHOW SOMETHING ELSE." -- WHAT DID THE CURVES SHOW? CURVES DO NOT SHOW GROWTH, CASE SOLVED (B)(4).
IT WAS REPORTED THAT WHILE RUNNING SAMPLES ON BD BACTEC¿ MGIT¿ 960 SYSTEM FALSE POSITIVE RESULTS ARE OBTAINED, HOWEVER, THE CURVES READ DIFFERENTLY. GRAM-STAIN WAS PERFORMED WITH RESULTS RETURNING AS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED TO CLINICIANS. THERE WAS NO ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MANY OF THE TUBES GIVE A POSITIVE RESULT AT 35 DAYS, WHILE THE CURVES SHOW SOMETHING ELSE. 1. WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? GRAM STAINING. 2. WERE ANY ERRONEOUS RESULTS REPORTED TO THE HEALTHCARE PROVIDER BY LABORATORY PERSONNEL? NO. 3. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. 4. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO. 5. ENTRY DESCRIPTION STATES: "WHILE THE CURVES SHOW SOMETHING ELSE." -- WHAT DID THE CURVES SHOW? CURVES DO NOT SHOW GROWTH, CASE SOLVED (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585081 | BD BACTEC¿ MGIT¿ 960 SYSTEM | SYSTEM, BLOOD CULTURING | MDB | BECTON, DICKINSON & CO. (SPARKS) | 445870 | NA | 00382904458706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |