MAUDE Adverse Event Report: THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC. THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC; MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS

Model Number GN7F

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2021

Event Type  malfunction  

Event Description

In collaboration with cdc and three other ar lab network public health laboratories, we evaluated the thermofisher sensititre gn7f panel.We followed the sensititre 037-nfast fda-usa only instructions for use -cid: 10253.Based on previous issues with a ruo sensititre panel (gnx2f), we evaluated whether the gn7f panel had similar performance issues.The five labs in this study followed the same protocol to evaluate the different transfer inoculum volumes (standard [10ul from 0.5 mcfarland equivalent to 11ml camhb] and increased [30ul from 0.5 mcfarland equivalent to 11ml camhb]) (see pg 4 in ifu).In addition, we evaluated the performance of the specific inoculum instructions for the proteeae tribe organisms (1ul from 0.5 mcfarland equivalent to 11ml camhb).These various inoculum levels were tested from the same 0.5 mcfarland equivalent to be able to compare the effect of these inoculum methods.Methods were otherwise according to the ifu, with the exception of two labs who used a turbidity meter instead of a sensititre nephelometer.All labs manually read the gn7f panel.In one lab, in addition to the manual read, read the panels with the aris 2x.All labs tested the same 100 organisms from the cdc & fda ar isolate bank (40 enterobacterales, 30 p.Aeruginosa, and 30 a.Baumannii).The greatest effect of the 1ul/10ul standard inoculum methods was observed for enterobacterales.All laboratories saw that using the 1ul with the proteeae tribe undercalled resistance, specifically in the beta-lactam agents.Amongst all laboratories, using the 1ul for proteeae tribe and 10ul for non-proteeae tribe, no lab could obtain essential agreement >90% for doripenem, ertapenem, imipenem, meropenem, cefepime, piperacillin-tazobactam.All labs observed at least 1 very major error (up to 5) for doripenem, ertapenem, meropenem, aztreonam, ceftolozane-tazobactam, and piperacillin-tazobactam.Increasing the transfer inoculum of all organisms to 30ul or 50ul (off-label) improved ea and very major error rates.Cdc was also a participant in this study.We've held multiple meetings with thermo fisher scientific regarding these problems, and were left unresolved.Data can be provided upon request.Lab specific details comments: multiple lots of plates and reagents were used sensititre gn7f plate lot(s): b0227a, b0336, b9521a sensititre dh2o lot(s): 920622, 922395, 996709 sensititre 11ml camhb lot(s): 114427, 920622, 922395, 992110 0.5 mcfarland turbidity equivalent method: microscan turbidity meter read method(s) (manual and/or autoread- include s/n for aris): manual.Fda safety report id # (b)(4).

• Brand Name: THERMOFISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC
• Type of Device: MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS
• Manufacturer (Section D): THERMO SCIENTIFIC /REMEL CLEVELAND, A DIVISION OF REMEL INC.
• MDR Report Key: 15078129
• MDR Text Key: 296469412
• Report Number: MW5111028
• Device Sequence Number: 10
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2022
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: GN7F
• Device Catalogue Number: GN7F
• Device Lot Number: 992110
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2022
• Patient Sequence Number: 1