MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ VAGINAL PANEL; VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM

Model Number 443712

Device Problem Non Reproducible Results (4029)

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

Event Date 02/26/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd max¿ vaginal panel on the bd max instrument, a false positive result was obtained.Confirmatory testing was performed.There was no indication that results were reported, and there was no report of patient impact."the following information was provided by the initial reporter: customer reports discrepant results.Customer reports that 1 patient specimen was triple positive for bv, c group, and c glabrata.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary the complaint investigation for discrepant results when using the bd max vaginal panel kit (ref.(b)(4)) lot 1286485 was performed by the review of the manufacturing records, retain material testing, analysis of the customer¿s data and verification of complaints history.Review of the manufacturing records of the bd max vaginal panel kit indicated that lot 1286485 was manufactured according to specifications and met performance requirements.The retain material of bd max vaginal panel kit from lot 1286485 was tested and the results met specifications.Customer reported one patient sample which gave bv, cgroup and cgla positive results but all targets tested negative upon repeat.Customer provided two run files #(b)(4) (initial test and #(b)(4) (repeat test) from bd max¿ instrument cr1423a for investigation.Manual pcr curve adjudication of the discrepant sample was done and revealed anomalies for the positive cgroup and cgla results.After review by a bd instrument quality engineer, an instrument service ticket was opened to assess a potential normalizer drift on the instrument cr1423a.For the bv discrepant, manual pcr curve adjudication showed high gardnerella vaginalis and low atopobium vaginae amplification in both initial and repeat testing.However, in the repeat testing, the amplification of one target (either bv or gv) was slightly lower than in the initial testing, and under the threshold to give a bv positive result.The fact that the value did not pass the threshold required shows that the sample was at the limit of detection of the assay, which resulted in a negative result for the repeat test.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max vaginal panel kit lot 1286485.The root cause was not identified.However, an instrument issue and positive sample at the limit of detection of the assay can explain the customer results.Overall, no reagents issue is suspected.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a preventive and corrective action plan since no reagent issue was identified.

Event Description

It was reported that while using the bd max¿ vaginal panel on the bd max instrument, a false positive result was obtained.Confirmatory testing was performed.There was no indication that results were reported, and there was no report of patient impact."the following information was provided by the initial reporter: customer reports discrepant results customer reports that 1 patient specimen was triple positive for bv, c group, and c glabrata.".

• Brand Name: BD MAX¿ VAGINAL PANEL
• Type of Device: VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13930153
• MDR Text Key: 298028954
• Report Number: 3007420875-2022-00012
• Device Sequence Number: 1
• Product Code: PQA
• UDI-Device Identifier: 00382904437121
• UDI-Public: 00382904437121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN160001
• 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: 04/18/2022

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
• Device Operator: Other
• Device Expiration Date: 10/04/2022
• Device Model Number: 443712
• Device Catalogue Number: 443712
• Device Lot Number: 1286485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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