MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ GBS; SEE H.10

Model Number 441772

Device Problem False Positive Result (1227)

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

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name:nucleic acid amplification assay system, group b streptococcus, direct specimen test medical device type or (procode) : njr, ooi.Initial reporter addr 1: (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 bd max¿ gbs discrepancy with the results occurred after rerun there was one negative result instead of a positive.The following information was provided by the initial reporter: gbs run 1909 - 7 samples - 2 pos; gbs run 1910 - 4 samples, including the 2 pos from run 1909: 1 of the repeats confirmed pos, and the other one is neg.

Event Description

It was reported that bd max¿ gbs discrepancy with the results occurred after rerun there was one negative result instead of a positive.The following information was provided by the initial reporter: gbs run 1909 - 7 samples - 2 pos; gbs run 1910 - 4 samples, including the 2 pos from run 1909: 1 of the repeats confirmed pos, and the other one is neg.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for discrepant results when using the bd max gbs (ref.(b)(4)) lot 2203774 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 2203774 indicated that the lot was manufactured according to specifications and met performance requirements.Customer complained about discrepant results when using the bd max¿ gbs assay.Two samples gave a gbs positive result in the initial run but one of them was negative upon repeat testing.Customer provided two run files #1909 and 1910 from instrument (b)(6) for investigation.Analysis of the run files revealed that in run 1909, 7 samples were tested with the bd max¿ gbs assay and two of them gave a positive gbs result.When retested in run 1910, one of them gave a negative result.Manual pcr curve adjudication of discrepant samples was performed.Pcr curves analysis revealed that in run 1909, both samples obtained late amplification of the gbs target (ct >29), which is unexpected with the gbs assay.Such late ct values are unexpected with the gbs assay, since samples are tested following an enrichment step.Based on the investigation, the most probable cause for the customer¿s discrepant results is suspected of being cross contamination introduced during the sample preparation at the customer¿s site or environmental contamination.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Nonetheless, no reagents issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max gbs lot 2203774.The root cause was not identified.However, a cross contamination introduced during the sample preparation at the customer¿s site can explain the customer¿s discrepant results.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and a preventive action plan since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

• Brand Name: BD MAX¿ GBS
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16380502
• MDR Text Key: 309595562
• Report Number: 1119779-2023-00119
• Device Sequence Number: 1
• Product Code: NJR
• UDI-Device Identifier: 00382904417727
• UDI-Public: 00382904417727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111860
• 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: 03/07/2023

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 Model Number: 441772
• Device Catalogue Number: 441772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1