MAUDE Adverse Event Report: THEROMOFISHER 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 04/29/2021

Event Description

This is related to another complaint submitted by (b)(6).Cdc performed side-by-side testing of thermofisher sensititre gn7f panels with our in-house reference broth microdilution panels on a small set of problematic organisms.Most of these organisms were of the proteae tribe, which have different final cfu/ml requirements than other gram-negative organisms.Cdc uses a turbidity meter for our ast methods, but we used sensititre dh2o tubes for the blank and to make the equivalent w/ org, in addition, we had a sensititre mcfarland standard, which read in-range (0.06) against a blank sensititre dh2o tube using the turbidity meter.We made our equivalents consistently at 0.06 to 0.07 even though the acceptable +/- range is larger.For gn7f, we used the aim to dispense into camhb into panels and sealed each plate w/ the sensititre films.We stacked 3 high in our incubator and read at approx.18 hrs.We read all the plates (reference and gn7f) manually with a non-magnifying mirror stand against a dark background (this is our standard for ast).Qc were tested at the levels, one failed at 50ul (35218 and ptz), but otherwise all were acceptable.Reference testing was done in accordance with our validated protocol.This a summary of results sent to thermofisher scientific via email: we also wanted to see how this affected the ar lab network.So we looked to see if we would miss any carbapenem-resistant isolates (cr=1; resistant to at least one carbapenem).We did not have doripenem for the side-by-side reference panel analysis on this test date, so this drug was not factored into the calculations below.However, you can see we would miss half of the isolates being falsely classified as carbapenem susceptible (cr=0); furthermore, 5/6 had a carbapenemase, so we would miss cp-cres.Camhb lot 992110 dh2o, lot 996709 gn7f, lot b0336.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): THEROMOFISHER SCIENTIFIC/REMEL CLEVELAND, A DIVISION OF REMEL INC.; oakwood village OH 44014
• MDR Report Key: 15078316
• MDR Text Key: 296415143
• Report Number: MW5111030
• Device Sequence Number: 1
• 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
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: GN7F
• Device Catalogue Number: GN7F
• Device Lot Number: 992110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1