VITEK® MS INSTRUMENT
Report
- Report Number
- 9615754-2022-00106
- Event Type
- Malfunction
- Date Received
- September 7, 2022
- Report Date
- October 4, 2022
- Manufacturer
- BIOMERIEUX SA
- Product Code
- QBN
- UDI-DI
- 03573026359119
- PMA / PMN Number
- K181412
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONTEXT: A CUSTOMER IN THE UNITED STATES INFORMED BIOMÉRIEUX OF MULTIPLE MISIDENTIFICATIONS IN ASSOCIATION WITH VITEK® MS INSTRUMENT (REF. (B)(4) , SERIAL NUMBER. (B)(6) ). THE RESULTS ARE SUMMARIZED BELOW: ACCESSION ID: 03974-1. VITEK MS RESULT: KLEBSIELLA PNEUMONIAE (EXPECTED RESULT STREP PYOGENES). MEDIA: BAP INCUBATED AT 18 HOURS. ACCESSION ID: 2622021789-1. VITEK MS RESULT: ROTHIA MUCILAGINOSA (EXPECTED RESULT E.COLI). MEDIA: MAC INCUBATED AT LESS THAN 24 HOURS. ACCESSION ID: KA08222-1. VITEK MS RESULT: KLEBSIELLA PNEUMONIAE (EXPECTED RESULT KLEB AEROGENES). MEDIA: BAP INCUBATED AT 24 HOURS. INVESTIGATION: BATCH HISTORY RECORD AND COMPLAINT TREND ANALYSIS. THERE IS NO CAPA RELATED TO THE CUSTOMER¿S COMPLAINT RECORDED. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE CONCLUDED WITH NO IMPLICATION OF A TREND. THIS COMPLAINT HAS NOT BEEN IDENTIFIED AS A SYSTEMIC QUALITY ISSUE. INVESTIGATION RESULTS: FINE TUNING: ACCORDING TO THE VILINK ALERT TOOL CRITERIA, NO FINE TUNING WAS NEEDED DURING THE TESTS PERFORMED ON 22 AUG 2022, SAME FOR TESTS PERFORMED ON THE 26 AND 27 AUG 2022. SPOT PREPARATION QUALITY: THE CALIBRATOR AND SAMPLE ¿ALL PEAKS¿ VALUES ARE QUITE HETEROGENEOUS. BASED ON THIS FINDING, THE SPOT PREPARATION QUALITY NEEDS TO BE VERIFIED WITH THE CUSTOMER. KNOWLEDGE BASE (KB) REVIEW: THE EXPECTED IDENTIFICATION FOR 03974-1 SEEMS TO BE STREPTOCOCCUS PYOGENES WHICH IS PRESENT IN THE VITEK MS KB V3.2. THE EXPECTED IDENTIFICATION FOR 2622021789-1 SEEMS TO BE ESCHERICHIA COLI WHICH IS PRESENT IN THE VITEK MS KB V3.2. THE EXPECTED IDENTIFICATION FOR KA08222-1 SEEMS TO BE KLEBSIELLA AEROGENES WHICH IS PRESENT IN THE VITEK MS KB V3.2. SAMPLE DATA ANALYSIS: ANALYSIS OF MZML SAMPLE FILE SHOWS THAT THE NUMBER OF "ALL PEAKS" AND THE SCORE LEVEL WERE GOOD. THE QUALITY OF THE SPECTRA WAS NOT QUESTIONED. EXPECTED IDENTIFICATION AFTER INVESTIGATION. UNKNOWN (SAMPLE NOT AVAILABLE TO CONFIRM ITS IDENTIFICATION). CONCLUSION: ROOT CAUSE ANALYSIS : UNKNOWN AS FURTHER INVESTIGATION ON THE STRAINS ARE NOT POSSIBLE.
HOLD FOR TD 12/01 INTENDED USE: VITEK® MS IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND MOULD INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES OF AMERICA INFORMED BIOMÉRIEUX OF MULTIPLE MISIDENTIFICATIONS IN ASSOCIATION WITH VITEK MS INSTRUMENT (B)(4). THE RESULTS ARE SUMMARIZED BELOW: ACCESSION ID: (B)(4). VITEK MS RESULT: KLEBSIELLA PNEUMONIAE (EXPECTED RESULT STREP PYOGENES). MEDIA: BAP INCUBATED AT 18 HOURS. ACCESSION ID: (B)(4). VITEK MS RESULT: ROTHIA MUCILAGINOSA (EXPECTED RESULT E.COLI). MEDIA: MAC INCUBATED AT LESS THAN 24 HOURS. ACCESSION ID: (B)(4). VITEK MS RESULT: KLEBSIELLA PNEUMONIAE (EXPECTED RESULT KLEB AEROGENES). MEDIA: BAP INCUBATED AT 24 HOURS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2683621 | VITEK® MS INSTRUMENT | VITEK® MS INSTRUMENT | QBN | BIOMERIEUX SA | 410895 | 03573026359119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |