MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ VAGINAL PANEL; SEE H.10

Catalog Number 443712

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  Injury  

Event Description

Report 1 of 2 it was reported that while using bd max¿ vaginal panel, a false positive result was obtained.The patient was treated with metronidazole and fluconazole.The following information was provided by the initial reporter: patient 1: ¿ 87 year old woman.¿ dx: pessary maintenance/female cystocele/uterine prolapse/rectocele/vaginal discharge.¿ treated with metronidazole and diflucan.Patient 1: on (b)(6) 2023 - ct1658 - v5.20 run #1369 in b7.K46 3137707 2024-04-16.Bv neg.C group pos.Ckru pos.Cgla pos.Tv tos.Max vaginal panel - 443712_3137707 - fps.

Manufacturer Narrative

D2: common device name: vaginitis and bacterial vaginosis nucleic acid detection system.A2: age or date of birth: date of birth was not available so 01/01 has been used.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

Report 1 of 2 it was reported that while using bd max¿ vaginal panel, a false positive result was obtained.The patient was treated with metronidazole and diflucan.The following information was provided by the initial reporter: patient 1: 87 year old woman.Dx: pessary maintenance/female cystocele/uterine prolapse/rectocele/vaginal discharge.Treated with metronidazole and diflucan patient 1 (b)(6) 2023- ct1658 - v5.20, run #1369 in b7, k46 3137707 2024-04-16, bv neg, c group pos, ckru pos, cgla pos, tv tos.Max vaginal panel - 443712_3137707 - fps.

Manufacturer Narrative

The following field has been updated with corrected information: b.5.Describe event or problem: report 1 of 2 it was reported that while using bd max¿ vaginal panel, a false positive result was obtained.The patient was treated with metronidazole and diflucan.The following information was provided by the initial reporter: patient 1: ¿ 87 year old woman ¿ dx: pessary maintenance/female cystocele/uterine prolapse/rectocele/vaginal discharge ¿ treated with metronidazole and diflucan patient 1 (b)(6) 2023 - ct1658 - v5.20 run #1369 in b7 k46 3137707 2024-04-16 bv neg c group pos ckru pos cgla pos tv tos max vaginal panel - 443712_3137707 - fps h.6.Investigation summary: the complaint investigation for discrepant results with the bd max¿ vaginal panel (ref.443712) lot 3137707 was performed by the review of the manufacturing records, customer¿s data analysis and verification of complaints history.Review of the manufacturing records of bd max vaginal panel indicated that lot 3137707 was manufactured according to specifications and met performance requirements.Customer complained about two patient samples which obtained a positive result for all targets of the vaginitis master mix (mm2, bottom position of the cartridge) when using the bd max¿ vaginal panel assay kit lot 3137707.Customer provided run files 1369 and 7616 from instruments ct1658 and ct0176 respectively for investigation.Manual pcr curve adjudication was performed.The pcr curve pattern of the two samples tagged by the customer showed a step dislocation in the raw pcr signal, generated positive results for all targets in run 1369 (position b7) and 7616 (position a1).It is unlikely that the step dislocations are due to true amplifications.Moreover, additional information received from the customer revealed that the positivity rate did not increase in (b)(6), (b)(6), and (b)(6) 2023 suggesting isolated events.Bd was unable to identify a cause for the atypical pcr signal, but the issue appears to have been isolated.There is no indication of an increase in complaints for discrepant results for bd max vaginal panel lot 3137707.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.

• Brand Name: BD MAX¿ VAGINAL PANEL
• Type of Device: SEE H.10
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18135459
• MDR Text Key: 328110741
• Report Number: 3007420875-2023-00101
• Device Sequence Number: 1
• Product Code: PQA
• UDI-Device Identifier: 00382904437121
• UDI-Public: (01)00382904437121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/16/2024
• Device Catalogue Number: 443712
• Device Lot Number: 3137707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female