MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ TAXO¿ A DISCS FOR DIFFERENTIATION OF GROUP A STREPTOCOCCI; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Model Number 231552

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

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while testing with the bd bbl¿ taxo¿ a discs for differentiation of group a streptococci, there was no zone of inhibition.Confirmatory testing was performed with a remel pathodx agglutination test, and the result was positive for strep group a.Result was reported as strep group a, and there was no report of patient impact.The following information was provided by the initial reporter: customer problem: customer is reporting no zone of inhibition with 231552 disc if media performance issue provide organism atcc strain information (if applicable): n/a steps taken with customer/troubleshooting: customer is reporting they are not getting a zone of inhibition with 231552 disc from lot 0343425.The customer states they did a wet prep on the organism and it was cocci in chains and there was clear hemolysis on the blood agar plate.The subbed to blood agar plate and dropped a 231552 disc and allowed the plate to grow in a 36 degree incubator overnight.The disc had no zone of inhibition around it.The customer decided to run a remel pathodx agglutination test and it came back positive for strep group a.Qc for the discs is run weekly and the customer reports they have not had any issues with qc passing.The customer mentioned that plate they set the disc to had heavy growth.I let the customer know in the package insert we state that an inoculum that is to heavy might result in no zone of inhibition.The customer is going to reset the isolate to a blood agar plate with a new disc and reduce the inoculum amount to see if that changes the result.I will follow up with them tomorrow to see if they get a zone of inhibition after the troubleshooting measure follow up call placed to customer.Customer states they reset two plates one with a isolate dilution and one not diluted.Neither plates showed a zone of inhibition.The customer also set up their positive and negative control isolates and the qc passed as expected.The customer reported out the isolate as probably group a strep and has indicated that they will send to a reference laboratory if requested by the doctor.They believe that this might actually be a group b strep at this point as the qc is performing as expected.They also believe this is an isolated event so they no longer wish to proceed forward with a formal investigation at this time.

Event Description

It was reported that while testing with the bd bbl¿ taxo¿ a discs for differentiation of group a streptococci, there was no zone of inhibition.Confirmatory testing was performed with a remel pathodx agglutination test, and the result was positive for strep group a.Result was reported as strep group a, and there was no report of patient impact.The following information was provided by the initial reporter: customer problem: customer is reporting no zone of inhibition with 231552 disc if media performance issue provide organism atcc strain information (if applicable): n/a steps taken with customer/troubleshooting: customer is reporting they are not getting a zone of inhibition with 231552 disc from lot 0343425.The customer states they did a wet prep on the organism and it was cocci in chains and there was clear hemolysis on the blood agar plate.The subbed to blood agar plate and dropped a 231552 disc and allowed the plate to grow in a 36 degree incubator overnight.The disc had no zone of inhibition around it.The customer decided to run a remel pathodx agglutination test and it came back positive for strep group a.Qc for the discs is run weekly and the customer reports they have not had any issues with qc passing.The customer mentioned that plate they set the disc to had heavy growth.I let the customer know in the package insert we state that an inoculum that is to heavy might result in no zone of inhibition.The customer is going to reset the isolate to a blood agar plate with a new disc and reduce the inoculum amount to see if that changes the result.I will follow up with them tomorrow to see if they get a zone of inhibition after the troubleshooting measure.Follow up call placed to customer.Customer states they reset two plates one with a isolate dilution and one not diluted.Neither plates showed a zone of inhibition.The customer also set up their positive and negative control isolates and the qc passed as expected.The customer reported out the isolate as probably group a strep and has indicated that they will send to a reference laboratory if requested by the doctor.They believe that this might actually be a group b strep at this point as the qc is performing as expected.They also believe this is an isolated event so they no longer wish to proceed forward with a formal investigation at this time.

Manufacturer Narrative

H6: investigation summary a complaint investigation due to no inhibition zone when using taxo a bacitracin catalog 231552 batch no.: 0343425 was performed on retention samples.Returned goods were not received from customer.The investigation required to test product for performance, potency assay, visual inspection, and batch record review.Retention samples performed as expected.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.H3 other text : see h10.

• Brand Name: BD BBL¿ TAXO¿ A DISCS FOR DIFFERENTIATION OF GROUP A STREPTOCOCCI
• Type of Device: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14025913
• MDR Text Key: 298431307
• Report Number: 2647876-2022-00083
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 30382902315521
• UDI-Public: 30382902315521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 231552
• Device Catalogue Number: 231552
• Device Lot Number: 0343425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1