MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ DRYSLIDE¿ OXIDASE; SEE H.10

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	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd bbl¿ dryslide¿ oxidase that there was false positives.The following information was provided by the initial reporter: batch with false positive oxidase test results.The e coli 25922 quality control gives a positive reaction in less than 20 seconds (expected negative result).The reagent is stored under the recommended conditions and even when opening a new card there is a fluctuation in the test response.The problems seem to be quite random but also present on some clinical strains.
Additional Manufacturer Narrative
Common device name: discs, strips and reagents, microorganism differentiation.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary: a complaint investigation due to false positive test results with dryslide oxidase catalog 231746 batch no.: 2125485 was performed on retention samples.Returned goods were not received from customer.The investigation required to test product for performance, visual inspection, and batch record review.Retention samples performed as expected.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaint is not confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd bbl¿ dryslide¿ oxidase that there was false positives.The following information was provided by the initial reporter: batch with false positive oxidase test results.The e coli 25922 quality control gives a positive reaction in less than 20 seconds (expected negative result).The reagent is stored under the recommended conditions and even when opening a new card there is a fluctuation in the test response.The problems seem to be quite random but also present on some clinical strains.

• Brand Name: BD BBL¿ DRYSLIDE¿ OXIDASE
• Common Device Name: SEE H.10
• 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: 16655379
• Report Number: 2647876-2023-00010
• Device Sequence Number: 15104912
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2023

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: 03/15/2023
• Supplement Date Received by Manufacturer: 04/29/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/12/2023
• 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