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

Model Number	448100
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	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.(b)(6).Pma/510(k) #: k020321, k040099, k131331.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd phoenix¿ automated microbiology system there was an error id result showing.No patient impact was reported.The following information was provided by the initial reporter: error id result showing.
Event or Problem Description
It was reported that while using the bd phoenix¿ automated microbiology system there was an error id result showing.No patient impact was reported.The following information was provided by the initial reporter: error id result showing.
Additional Manufacturer Narrative
H.6 investigation summary: a failure was reported on a phoenix 100 instrument (p/n 448100, s/n (b)(6)).A field service engineer (fse) was dispatched and proceeded to clean the instrument.Once the fse performed the cleaning the issue was resolved.The root cause is not able to be determined.This is an unconfirmed failure of a bd product.Samples were not received by quality for investigation and thus, returned material investigation could not occur.If samples are received at a later date, the complaint may be reopened.This complaint is not an early life failure (elf) of the device.Since the installation of this instrument, there have been service events, including pms (preventative maintenance) which have altered the instrument from its original state.Therefore, review of the device history record (dhr) from manufacturing is not applicable.Service history review for this instrument was completed and revealed no previous complaints related to results issues.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.Per baltrmphxidastinstraph rev 6 the potential risk of the reported failure mode is user annoyance, which is an s1; reference row id 9.12.

• Brand Name: BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15613207
• Report Number: 1119779-2022-01304
• Device Sequence Number: 5810771
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: 00382904481001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: SEE H.10
• 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): 11/29/2022

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 Model Number: 448100
• Device Catalogue Number: 448100
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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