MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST INDICATOR SOLUTION; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number	246004
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using kit flu a+b 30 test physician veritor atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "report an increase in cases of panel abortion due to alarm: insufficient amount of indicator.".
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6 investigation summary this complaint is for insufficient drop-size of ast indicator (246004) batch 1076218.No product returns were provided for investigation.To investigate, ten drops from two retention bottles of ast indicator from the complaint batch were weighed with an expected nominal target of 40ul / 0.04 grams.All 20 drops were within this nominal target range.This complaint is not confirmed.A review of quality notifications revealed no quality notifications for this defect.A review of complaints revealed eleven additional complaints on the complaint batch.Complaint trending was performed and no trends were identified for this defect.Bd id/ast plant quality will continue to monitor for trends associated with this defect.Please continue to communicate any additional concerns.H3 other text : see h10.
Event or Problem Description
It was reported that while using kit flu a+b 30 test physician veritor atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " report an increase in cases of panel abortion due to alarm: insufficient amount of indicator.".

• Brand Name: BD PHOENIX¿ AST INDICATOR SOLUTION
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12436743
• Report Number: 1119779-2021-01480
• Device Sequence Number: 11657772
• Product Code: LON
• UDI-Device Identifier: 30382902460047
• UDI-Public: 30382902460047
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K020321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 246004
• Device Catalogue Number: 246004
• Device Lot Number: 1076218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown