MalfunctionJWY
SENSITITRE GRAM NEGATIVE IVD AST SENSITITRE PLATE
Received Dec 5, 2024
Report MW5163355 · MDR key 20866277
Device
Generic name
Manual Antimicrobial Susceptibility Test Systems
Manufacturer
Trek Diagnostic Systems, Ltd.Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Material Integrity Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 4/30/2025 FOR REPORT MW5163355 TO UPDATE THE PROCODE.
Description of Event or Problem
THERMO SCIENTIFIC GRAM NEGATIVE IVD AST SENSITITRE PLATE, URGENT MEDICAL DEVICE CORRECTION ISSUED OCTOBER 2022 STILL HAS NOT BEEN RESOLVED AND MANUFACTURER DOES NOT RESPOND TO REQUESTS FOR UPDATES. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AR ISOLATE 0057 TESTS FALSELY SUSCEPTIBLE ON THE SENSITITRE GRAM NEGATIVE PANEL FOR THE FOLLOWING ANTIBIOTICS: CEFEPIME, ERTAPENEM, MEROPENEM, PIPERACILLIN/TAZOBACTAM.