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U.S. Department of Health and Human Services

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

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THERMO SCIENTIFIC / REMEL CLEVELAND, A DIVISION OF REMEL INC. THERMO FISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC OR BREAKPOINT SUSCEPTIBILITY MANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS Back to Search Results
Model Number GN7F
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Volume Accuracy Problem (1675); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 07/31/2021
Event Type  malfunction  
Event Description
In collaboration with cdc and four 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. Data can be provided upon request. The product was advertised as fda cleared. Laboratories were unable to verify product performance as advertised. Alterations in use requiring a full validation were necessary. Proteae members were diluted 1:11,000 (1 ¿l into 11 ml) per manufacturer's package insert. Using this concentration produced errors and the process had to be modified to meet standards. Validating the panel required 30 ul inoculum for all species and a manual reading of the proteeae tribe to meet validation standards. Sensititre gn7f plate lot(s): b0121a, b0227a, lot b1384 sensititre dh2o, lot(s): sensititre 11ml camhb, lot(s): 407693. Fda safety report id# (b)(4).
 
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Brand NameTHERMO FISHER SCIENTIFIC SENSITITRE 18-24 HOUR MIC OR BREAKPOINT SUSCEPTIBILITY
Type of DeviceMANUAL ANTIMICROBIAL SUSCEPTIBILITY TEST SYSTEMS
Manufacturer (Section D)
THERMO SCIENTIFIC / REMEL CLEVELAND, A DIVISION OF REMEL INC.
oakwood village OH 44014
MDR Report Key14946169
MDR Text Key295514076
Report NumberMW5110708
Device Sequence Number1
Product Code JWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/01/2022
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGN7F
Device Catalogue NumberGN7F
Device Lot NumberB0121A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

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