MAUDE Adverse Event Report: BECKMAN COULTER WALKAWAY96 PLUS; INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPTIBILITY SYSTEM

Model Number	B1018-284
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Septic Shock (2068); Urinary Tract Infection (2120)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported misreads appear to be due to a combination of poor technique by the operator and component malfunctions on the instrument.Beckman technical application specialist provided onsite training for the customer on proper panel setup technique.Beckman field service engineer (fse) replaced the potassium hydroxide reagent bottle and the solenoid valve to resolve the instrument issues.The customer has not reported any further issues with misreads since the onsite training and service visit.(b)(4).
Event or Problem Description
Customer reported issues with low probability identifications and (b)(6) resistant misreads when compared to visual read.Customer indicated they had two specimens where erroneous results were reported.First specimen reported as (b)(6).Upon repeat, the isolate identified as (b)(6).The (b)(6) result was reported out and questioned.The patient had a specimen run several days prior that resulted as (b)(6).The (b)(6) result was obtained on (b)(6) 2019.Physician began (b)(6) treatment for the (b)(6) years old female diagnosed with septic shock.After the repeat result of (b)(6) was obtained on (b)(6) 2019, the customer indicated the treatment was going to be changed to (b)(6).Second specimen was very resistant and tested as escherichia coli esbl negative on (b)(6) 2019.Upon repeat on (b)(6) 2019, the organism tested as esbl negative again but was manually edited to positive based on visual read of the panel.The patient was a (b)(6) years old male with a urinary tract infection.Customer did not know what the initial treatment was; the amended treatment was meropenem.There was a third specimen however no erroneous results were reported.The isolate tested as klebsiella oxytoca esbl negative however customer changed to esbl positive based on visual inspection of the panel.Panel data was reviewed and did not indicate an obvious instrument issue.The customer did report occasional mixed cultures and that new personnel were setting up panels.While the beckman technical application specialist (tas) was onsite providing an in-service training for panel setup and visual reads, it was noted that the potassium hydroxide reagent bottle had run empty due to a failed reagent level sensor; this caused some misidentifications.Beckman field service engineer (fse) found during the site visit that in addition to the failed sensor, the peptidase reagent valve was leaking, which may have also contributed to incorrect panel results.The reported misreads appear to be due to a combination of poor technique by the operator and component malfunctions on the instrument.Beckman coulter customer technical support inquired about the patient conditions for the original specimens reported with misreads - customer spoke with the physician who said the only issue was that they had extended hospital stays but no specific details were provided.

• Brand Name: WALKAWAY96 PLUS
• Common Device Name: INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPTIBILITY SYSTEM
• Manufacturer (Section D): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• MDR Report Key: 9287658
• Report Number: 2919016-2019-01002
• Device Sequence Number: 19423967
• Product Code: LRG
• UDI-Device Identifier: 15099590658687
• UDI-Public: (01)15099590658687(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K911400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: B1018-284
• Device Catalogue Number: B1018-284
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR