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

Model Number 443712

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown (b)(4).

Event Description

It was reported while testing with bd max¿ vaginal panel a (b)(6) for trichomonas was obtained.Sample was repeated and result was negative.Reported as negative.

Event Description

It was reported while testing with bd max¿ vaginal panel a false positive for trichomonas was obtained.Sample was repeated and result was negative.Reported as negative.

Manufacturer Narrative

The following fields were updated due to additional information: d.4.Medical device lot #: 0259582 d.4.Medical device expiration date: 9/15/2021 h.4.Device manufacture date: 9/15/2020 h.6.Investigation: the complaint investigation for discrepant results with the bd max vaginal panel (ref 443712) lot 0259582 was performed by the review of the manufacturing records, customer¿s data analysis and verification of complaints history.Initially, customer did not provide kit lot number but analysis of the customer data revealed that bd max¿ vaginal panel kit lot 0259582 was used to test the sample.Review of the manufacturing records of bd max vaginal panel indicated that lot 0259582 was manufactured according to specifications and met performance requirements.Customer reported a discrepant result for a patient sample for the cgla and tv targets while using the bd max¿ vaginal panel and provided two databases from instruments ct1266 and ct1364 for investigation.Database analysis allowed to identify discrepant results in 3 runs (runs 3297 and 3298 on ct1266 and run 1249 on ct1364).The sample was initially tested in run 3297(position a3), and gave an unresolve (unr) results for all targets, which could be linked with specimen-associated interfering/ inhibiting substance.The same sample buffer tube was repeated in run 3298 position a8, as mentioned in the complaint text, and gave cgla and tv positive results.When the same sample buffer tube was repeated in run 1249, on instrument ct1364 with another kit lot (0259581), all the targets gave a negative result.However, retest of the same sample buffer tube three times is an off-label use of the bd max¿ vaginal assay.Manual pcr curve adjudication was performed on the sample in run 3298 position a8.Manual curve adjudication has limitations; visual examination of pcr curves for low signal and/or aberrant curve geometry is an extremely conservative assessment of the data.Analysis of the pcr curve of run 3297 shows a step dislocation in the raw pcr signal of every channels and generated positive tv and cgla results.However, it is unlikely that those step dislocations are due to true amplification but a root cause for those discrepant results could not be identified.There is no indication of an increase in complaints for discrepant results for bd max vaginal panel lot 0259582.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.H3 other text : see h.10.

• Brand Name: BD MAX VAGINAL PANEL
• Type of Device: VAGINITIS & BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 11374580
• MDR Text Key: 247509318
• Report Number: 3007420875-2021-00005
• Device Sequence Number: 1
• Product Code: PQA
• UDI-Device Identifier: 00382904437121
• UDI-Public: 00382904437121
• Combination Product (y/n): N
• PMA/PMN Number: DEN160001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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: 09/15/2021
• Device Model Number: 443712
• Device Catalogue Number: 443712
• Device Lot Number: 0259582
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1