MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM; SARS-COV-2 REAGENT KIT

Catalog Number 44500301

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

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Eua# (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while testing for sars-cov-2 false positive results occurred.Samples were repeated by laboratory personnel and were negative.There was no report of patient impact.(b)(4).

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 0168224.D.4.Medical device expiration date: 2020-12-29.H.4.Device manufacture date: 2020-06-16.D.4.Medical device lot #: 0168233.D.4.Medical device expiration date: 2021-01-04.H.4.Device manufacture date: 2020-06-16.

Event Description

It was reported that while testing for sars-cov-2 false positive results occurred.Samples were repeated by laboratory personnel and were negative.There was no report of patient impact.(b)(4).

Event Description

It was reported that while testing for sars-cov-2 false positive results occurred.Samples were repeated by laboratory personnel and were negative.There was no report of patient impact.Eua# (b)(4).

Manufacturer Narrative

Investigation: the complaint investigation for false positive when using the bd max sars-cov-2 reagents (ref# 44500301) lot 0168224 was performed by the review of the manufacturing records, review of customer¿s data, and by the complaint¿s history review.Review of the manufacturing records of bd max sars-cov-2 reagents¿ indicated that the lot 0168224 was manufactured according to specifications and met performance requirements.Customer reported 3 false positives when using the bd sars-cov-2 kit on bd max with, at least, one known negative sample as negative control.Despite multiple attempts made to receive information from the customer, no data was provided for the investigation.Without available data, bd is unable to confirm the root cause.There is no indication of an increase in complaints for false positive results for the bd sars-cov-2 lot 0168224.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.

• Brand Name: BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM
• Type of Device: SARS-COV-2 REAGENT KIT
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 10817469
• MDR Text Key: 215578348
• Report Number: 1119779-2020-00960
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/04/2021
• Device Catalogue Number: 44500301
• Device Lot Number: 0168233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1