MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX GBS; NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM

Model Number 441772

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

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd max¿ gbs false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: gbs assay discrepant results and negative control failure.

Manufacturer Narrative

H6: investigation summary: the complaint investigation for discrepant result when using the bd max gbs (b)(4) lot 0167796 was performed by the review of the manufacturing records, analysis of the customer¿s data and verification of the complaints history.Review of the manufacturing records of the bd max gbs lot 0167796 indicated that the lot was manufactured according to specifications and met performance requirements.Customer complained about discrepant results on one sample and negative control failures in runs 529 and 530.The patient specimen gave a positive result in run 529 but when repeated in run 530, it tested negative.The two runs were provided for the investigation and analyzed.Manual pcr curve adjudication was also performed.In run 529, 3 patient specimens as well as a negative control and a positive control were tested, and all gave a positive result.The positive control as well as one patient specimen (tested in position a1) gave strong gbs positive results, with cycle threshold (ct) values around 14, whereas one patient specimen (tested in a3) gave a moderate ct of 26.The last patient specimen, tested in a2 as well as the negative control, both gave late positive results, with ct values near 31-33.When retested in the subsequent run, the patient sample from position a2 gave a negative result but the negative control remained gbs positive, with a similar ct of 34.Such late positive results strongly suggest false positive results due to cross-contamination during samples preparation or from the environment.The complaint text mentioned this customer is an inexperienced bd max user.After recommendations from bd, environmental monitoring was performed by the customer, which confirmed probable environmental contamination since 4 environmental swabs gave positive results.There is no indication of an increase in complaints for discrepant result for bd max gbs lot 0167796.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.No corrective and preventive action (capa) was initiated.Customer was advised to introduce regular em¿s to detect potential environmental contamination and take appropriate actions to avoid other contamination episodes.Bd quality will continue to monitor for trends.H3 other text : see h10.

Event Description

It was reported that while using bd max¿ gbs false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "gbs assay discrepant results and negative control failure".

• Brand Name: BD MAX GBS
• Type of Device: NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 12054242
• MDR Text Key: 268261573
• Report Number: 3007420875-2021-00025
• Device Sequence Number: 1
• Product Code: NJR
• UDI-Device Identifier: 00382904417727
• UDI-Public: 00382904417727
• Combination Product (y/n): N
• PMA/PMN Number: K111860
• 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: 08/20/2021

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: 09/05/2021
• Device Model Number: 441772
• Device Catalogue Number: 441772
• Device Lot Number: 0167796
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1