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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd macro-vue¿ rpr card test there was a possible false positive.Some of the samples were repeated but not all of them and some patients would reflex to tp-pa.Patient sample results were not reported to the clinician and there was no patient impact.The following information was provided by the initial reporter: customer is reporting a possible false positive for the product 275005 lot#2013911 customer started testing with lot 2013911 on (b)(6) 2022.Shipment was received in june and stored in refrigerator.Customer says they received 30 kits of affected lot.They have tested at least 3 kits and got same weak reactivity with negative qc.The rpr antigen lot # 2013911 exp.1/31/2024 appears to be grainier than usual that even the nonreactive control looks like weak reactive.In spite of it being grainy, we continued to use the antigen because we don¿t have any other lot number to use and we have a lot of patients to run every day.
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.
Additional Manufacturer Narrative
H.6 investigation summary: satisfactory results when retention samples were tested for performance using three (3) sera panel numbers of each reactivity.Self sample results: serum no.15: control, retention and rg, showed reactive results at 1:1 to 1:4 and reactive minimal at 1:8.Serum no's; 17: control and retention showed reactive results at 1:1 and reactive minimal at 1:4.Serum no¿s 17 returned goods showed reactive at 1:1 and reactive minimal at 1:2.Serum no¿s.18: control, retention sample and returned goods showed reactive results at 1:1 and reactive minimal at 1:2.Serum no¿s.26: control, retention sample and returned goods showed reactive minimal results at 1:1.Serum no¿s.30: control showed reactive minimal at 1:1 to 1:2.Serum no¿s.30: retention sample and returned goods showed reactive minimal at 1:1.Serum no¿s.38: control showed reactive minimal at 1:1.Serum no's.7, 8 and 9: all lots showed negative results.Visual inspection was performed to retention samples, returned goods and no discrepancy were found.Batch record review do not show any discrepancy.Complaint unconfirmed based of retention, returned goods` test results and batch history record review.Complaint unconfirmed 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.
Event or Problem Description
It was reported that while using bd macro-vue¿ rpr card test there was a possible false positive.Some of the samples were repeated but not all of them and some patients would reflex to tp-pa.Patient sample results were not reported to the clinician and there was no patient impact.The following information was provided by the initial reporter: customer is reporting a possible false positive for the product 275005 lot#2013911.Customer started testing with lot 2013911 on 8/13/2022.Shipment was received in june and stored in refrigerator.Customer says they received 30 kits of affected lot.They have tested at least 3 kits and got same weak reactivity with negative qc.The rpr antigen lot # 2013911 exp.1/31/2024 appears to be grainier than usual that even the nonreactive control looks like weak reactive.In spite of it being grainy, we continued to use the antigen because we don¿t have any other lot number to use and we have a lot of patients to run every day.

• 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: 15397337
• Report Number: 2647876-2022-00193
• Device Sequence Number: 14983440
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 10/06/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/10/2022
• 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): Yes
• 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