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

Model Number 441772

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

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Common device name: nucleic acid amplification assay system, group b streptococcus, direct specimen test.

Event Description

It was reported that while using bd max¿ gbs 2 (b)(6) results were obtained by the laboratory personnel.Repeat testing was used to confirm the results as (b)(6).There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

The following fields were updated due to corrected information: d.10.Device available for eval? no.D.10.Returned to manufacturer on: na.H.6.Investigation: the complaint investigation for discrepant result when using the bd max gbs (ref 441772), lot: 0269552 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: 0269552 indicated that the lot was manufactured according to specifications and met performance requirements.Customer complained about three discrepant results with the bd max¿ gbs kit lot: 0269552.The six patient samples were tested in 3 different runs and for 3 of them, discrepant results were obtained.The initial test was performed in run#: 3209 and the re-tests were performed in runs 3210 and 3212 respectively.Customer provided theses three runs (3209, 3210 and 3212) for investigation.The three discrepant samples are #3, #5 and #6.The samples (#1 and #4) gave a strong positive result the three times (ct between 16.91 and 18.89), sample #2 gave negative results the three times, whereas the three discrepant samples gave weak positive results (ct between 27.74 and 38.41).Since the bd max¿ gbs assay has an enrichment step prior to testing on the instrument, the expected ct values for a positive sample are usually between 12 and 25.Therefore, the late positive results strongly suggest false positive results due to cross-contamination when preparing the samples or from the environment.Pcr amplification curves were analyzed, and manual pcr curve adjudication was conducted.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.Samples #1 and 4, from run 3209, show earlier increase of the pcr amplification compared to the other positive samples of the run.In the two other runs (#3210 and 3212), these two positive samples still show strong pcr amplification, with similar ct values, but the other samples are late and low, which support the contamination hypothesis.Additional environmental monitoring was performed by the customer and the results were all negative.Bd was unable to confirm the exact cause of the customer¿s results.Overall, no product issue is suspected.There is no indication of an increase in complaints for discrepant result for bd max gbs lot: 0269552.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.

Event Description

It was reported that while using bd max¿ gbs 2 false positive results were obtained by the laboratory personnel.Repeat testing 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.

• Brand Name: BD MAX GBS
• Type of Device: SEE H.10.
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 11548008
• MDR Text Key: 247514855
• Report Number: 3007420875-2021-00008
• 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: 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: 04/09/2022
• Device Model Number: 441772
• Device Catalogue Number: 441772
• Device Lot Number: 0269552
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/22/2021
• 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