MAUDE Adverse Event Report: FISHER SCIENTIFIC CO., LLC. SENSITITRE ARIS; INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUS

Model Number TREK SENSITITRE ARIS

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Four enterococcus isolates (including one cap isolate) tested false susceptible to high-level gentamicin (500 ug/ml).Thermo fisher has undertaken multiple attempts to identify the issue including servicing of the nephelometers for organism concentration, servicing of the instrument for temperature and optical performance, and reagent lot-to-lot variation.Testing of isolates by thermo fisher staff on our instruments revealed false susceptible results.Investigation was initiated late summer of 2014.Initial testing of all four isolates at thermo fisher facility on their instruments demonstrated resistance; however, further testing of the isolates at their facility on their instruments gave variable results of sensitive or resistant.At present, due to the very major errors identified, we cannot use sensititre for high-level gentamicin testing and are awaiting a practical resolution of this problem from thermo fisher.For the cap isolate, 997 laboratories reported high-level gentamicin by broth or agar dilution; 885 (98.7%) laboratories reported the result correctly as resistant.The consequence to the laboratory of these very major errors includes additional offline testing via disk diffusion for high-level gentamicin for all enterococcus isolates for clinical reporting.The device may have contributed to: potential patient harm through the reporting of false susceptible high-level gentamicin results.Manufacturer response for laboratory instrument, trek sensititre aris (per site reporter).
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thermo fisher has undertaken multiple attempts to identify the issue including servicing of the nephelometers for organism concentration, servicing of the instrument for temperature and optical performance, and reagent lot-to-lot variation.Testing of isolates by thermo fisher staff on our instruments revealed false susceptible results.Investigation was initiated late summer of 2014.

• Brand Name: SENSITITRE ARIS
• Type of Device: INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUS
• Manufacturer (Section D): FISHER SCIENTIFIC CO., LLC.; one reagent ln.; fair lawn NJ 07410
• MDR Report Key: 4373729
• MDR Text Key: 15963735
• Report Number: 4373729
• Device Sequence Number: 1
• Product Code: JWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: TREK SENSITITRE ARIS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2014
• Patient Sequence Number: 1