MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD MACRO-VUE¿ RPR CARD TEST; ANTIGENS, NONTREPONEMAL, ALL

Model Number	275005
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
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 macro-vue¿ rpr card test false negatives occurred.The following information was provided by the initial reporter: negative result the particles are too coarse.
Event or Problem Description
It was reported that bd macro-vue¿ rpr card test false negatives occurred.The following information was provided by the initial reporter: negative result the particles are too coarse.
Additional Manufacturer Narrative
No further clarification provided but ar codes updated to false positive.H.6 investigation summary material 275005 batch 2013911.Satisfactory results when retention samples were tested for performance using three (3) sera panel numbers of each reactivity.Retention sample results: control lot (2276961) customer batch number (2013911) serum no.14: control and retention, showed reactive results at 1:1 to 1:4 and reactive minimal at 1:8.Serum no's; 17 and 20: control and retention showed reactive results at 1:1 and reactive minimal at 1:4.Serum no¿s.26, 37 and 40 : control and retention sample showed reactive minimal results at 1:1.Serum no's.1, 6 and 10; all lots showed negative results.Visual inspection was performed to retention samples and no discrepancy were found.Normal particle size was observed.Photo evaluation was performed; grainy can not be defined through the customer photo.Batch history records were reviewed with satisfactory results, no deviations were reported.In-process and qc testing were within specification.Complaint is unconfirmed based of retention sample test results and batch history record review and photo evaluation.Special attention should be provided to: antigen storage and use.Sample and room temperature during the test.Type of specimen used: collection and preparation.According of the ¿manual of test for syphilis¿ edition 9.0 the following ¿sources of error¿ had been identified for increase of reactivity or false reactivity for the rpr test.If the time of rotation is too long, test reactivity may be increased.If the card is excessively rotated and tilted (to and fro motions) by hand after removal from the rotator, a false reactive result may occur.If the serum is unevenly spread in the circle, the antigen and the antibody may not mix properly.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.H3 other text : see h.10.

• Brand Name: BD MACRO-VUE¿ RPR CARD TEST
• Common Device Name: ANTIGENS, NONTREPONEMAL, ALL
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15887083
• Report Number: 3008352382-2022-00011
• Device Sequence Number: 12091216
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: 01/31/2024
• Device Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: 2013911
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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