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

Catalog Number 444213

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2021

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 prior to use with biogx sars-cov-2 open system reagents for bd max¿ system the n2 reagent in pouch had orange cap instead of red.Eua# (b)(4).

Manufacturer Narrative

Investigation summary: the complaint investigation for incorrect labelled master mix pouches in the biogx sars-cov-2 osr assay (ref #444213) kit lot k20-509 was performed by biogx, product manufacturer.The investigation was performed by the review of the manufacturing records, review of customer¿s picture and by the complaint¿s history review.Customer reported that that the n2 reagent pouch had orange foil reagent and n1 reagent pouch also had orange foil reagent and provided picture for investigation.The pictures show a pouch with n2 label containing reagent tubes with orange foil seals.Reminder the master mix tubes are color-coded: n1 tubes use orange foil seals and n2 tubes use red foil seals.Biogx confirmed that master mix pouches externally labeled as containing n2 tubes were containing n1 tubes.Biogx review of the manufacturing records indicated that this kit lot k20-509 was affected by a human error.A change of packaging site has contributed to a human error during the labelling process of master mix pouches.Biogx confirm the complaint based on the review of manufacturing record and the picture provided.There is an indication of an increase in complaints for incorrect labelling in the biogx sars-cov-2 osr product.The root cause of the customer issue was a human error during labelling process.Biogx product manufacturer has initiated a preventive and corrective action plan.Bd has also initiated a capa (2208364).

Event Description

It was reported that prior to use with biogx sars-cov-2 open system reagents for bd max¿ system the n2 reagent in pouch had orange cap instead of red.(b)(4).

• Brand Name: BIOGX SARS-COV-2 OPEN SYSTEM 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: 11267821
• MDR Text Key: 234474988
• Report Number: 1119779-2021-00216
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/14/2021
• Device Catalogue Number: 444213
• Device Lot Number: K20-509
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1