MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ DRYSLIDE¿ OXIDASE; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Model Number	231746
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
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 bd bbl¿ dryslide¿ oxidase 2 strain tests came back positive but should be negative.The following information was provided by the initial reporter: the media are columbia biomérieux and the strains are atcc reference strains all 3 strains are positive in less than 20 seconds while e.Coli and k.Pneumoniae should be negative.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 3008352382-2023-00084 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that bd bbl¿ dryslide¿ oxidase 2 strain tests came back positive but should be negative.The following information was provided by the initial reporter: the media are columbia biomérieux and the strains are atcc reference strains all 3 strains are positive in less than 20 seconds while e.Coli and k.Pneumoniae should be negative.

• Brand Name: BD BBL¿ DRYSLIDE¿ OXIDASE
• Common Device Name: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17020624
• Report Number: 3008352382-2023-00084
• Device Sequence Number: 17728121
• Product Code: JTO
• UDI-Device Identifier: 30382902317464
• UDI-Public: 30382902317464
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K896398
• 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): 07/06/2023

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: 05/31/2023
• Device Model Number: 231746
• Device Catalogue Number: 231746
• Device Lot Number: 2125485
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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