MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL SENSI-DISC CEFEPIME - 30 G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Model Number	231696
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	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bbl¿ sensi-disc¿ cefepime - 30 ¿g a false susceptibility result was obtained by the laboratory personnel.The customer stated there was no patient impact.The following information was provided by the initial reporter: customer problem: customer reports 231696 lot: 0042052 has discrepant results steps taken with customer/troubleshooting: opened a complaint.Customer is performing a study and comparing bd sensi discs to vitek 2 results.Customer reports that three klebsiella pneumoniae esbl isolates have zones that interpret as resistant but when the same isolate is run on the vitek 2 the result is sensitive.Followed up for additional details via phone but customer has left for the day.
Additional Manufacturer Narrative
H6: investigation summary: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3008352382-2021-00113 was sent in error.It was determined the results were for a study and therefore not reportable.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd bbl¿ sensi-disc¿ cefepime - 30 g a false susceptibility result was obtained by the laboratory personnel.The customer stated there was no patient impact.The following information was provided by the initial reporter: "customer problem: customer reports 231696 lot: 0042052 has discrepant results steps taken with customer/troubleshooting: opened a complaint.Customer is performing a study and comparing bd sensi discs to vitek 2 results.Customer reports that three klebsiella pneumoniae esbl isolates have zones that interpret as resistant but when the same isolate is run on the vitek 2 the result is sensitive.Followed up for additional details via phone but customer has left for the day.".

• Brand Name: BD BBL SENSI-DISC CEFEPIME - 30 G
• Common Device Name: SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11645008
• Report Number: 3008352382-2021-00113
• Device Sequence Number: 4331045
• Product Code: JTN
• UDI-Device Identifier: 30382902316962
• UDI-Public: 30382902316962
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K961188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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 Expiration Date: 08/31/2021
• Device Model Number: 231696
• Device Catalogue Number: 231696
• Device Lot Number: 0042052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1