MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE

Model Number	441007
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd epicenter¿ single user software misidentified i for cefepime, even with no mic antibiotic on the panel.It was not confirmed that repeat tests were performed, and the erroneous results were not reported to the clinicians.There was no adverse patient impact.The following information was provided by the initial reporter: (b)(6)triggered creating an interpretation of i for cefepime, despite there being no mic for this antibiotic on the panel.Sample (b)(4) (2 panels tested with same result, same organism despite being given different isolate numbers" were patient samples involved? yes.Is a confirmatory test always performed? no.Was it obvious that the results were erroneous/could not be trusted? no (only identified as hsl).Were erroneous results reported to the clinician? no.Were patients treated based on erroneous results? no.If yes, was there any negative impact to the patient? no.
Event or Problem Description
It was reported that the bd epicenter¿ single user software misidentified i for cefepime, even with no mic antibiotic on the panel.It was not confirmed that repeat tests were performed, and the erroneous results were not reported to the clinicians.There was no adverse patient impact.The following information was provided by the initial reporter: "expert rule 988 triggered creating an interpretation of i for cefepime, despite there being no mic for this antibiotic on the panel.Sample 21f079700 (2 panels tested with same result, same organism despite being given different isolate numbers" q.Were patient samples involved?: yes.Q.Is a confirmatory test always performed?: no.Q.Was it obvious that the results were erroneous/could not be trusted?: no.(only identified as hsl) q.Were erroneous results reported to the clinician?: no.Q.Were patients treated based on erroneous results?: no.Q.If yes, was there any negative impact to the patient?: no.
Additional Manufacturer Narrative
H6: investigation summary: customer reported epicenter (441007) serial number (b)(6) using pud 6.81 expert rule 988 triggered creating an interpretation of i for cefepime, despite there being no mic for this antibiotic on the panel.Sample 21f079700 (2 panels tested with same result, same organism despite being given different isolate numbers.) there was no clinical impact to patient.21f079700 ¿ patient had bukhoderia- we do not report phoenix ast.Further investigation into this issue that this was a case not accounted for in rule 982 as well as similar rules.This has been updated in pud v7.01.Below is an excerpt from the nonfda customer release notes: 982¿992, 996 : these rules address the eucast breakpoints for which there is no intended ¿s¿ or ¿susceptible¿ interpretation.Mics can be interpreted as ¿r¿ for ¿resistant¿ or ¿i¿ for ¿susceptible, increased exposure.¿ the logic for these rules was modified in this pud release to prevent the inadvertent reporting of ¿i¿ or ¿susceptible, increased exposure¿ in instances where there was a failure in the ast of the drug on the bd phoenix¿ panel.This change in logic is not visible in the rule tables in the bdxpert user's manual for pud v7.01.Bd phoenix¿ customers currently using pud v6.81, whom do not wish to upgrade to pud v7.01, should disable these rules to prevent the reporting of ¿i¿ or ¿susceptible, increased exposure¿ for scenarios where the ast of the drugs included in these rules have failed on the bd phoenix¿ panel.Upgrading the customer to pud v7.01 will resolve the issue.One important note: if using the phoenix 100, the customer must first be upgraded to system software v6.41 and then install pud v7.01.This is a confirmed complaint of a bd product.Dhr review is not required for stand alone software.

• Brand Name: BD EPICENTER¿ SINGLE USER SOFTWARE
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12759372
• Report Number: 1119779-2021-01769
• Device Sequence Number: 14601310
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 441007
• Device Catalogue Number: 441007
• Device Lot Number: PUD6.81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown