MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC-106; FULLY AUTOMATED SHORT TERM INCUBATION AST

Model Number	448416
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	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported lot# 0356034 was not found for the reported catalog# 448416.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd phoenix¿ (b)(4) misidentified 2 results, with the top analyzer reading them differently than the bottom one.There was no indication of confirmatory testing, and results were not reported to clinicians.There was no report of patient impact.The following information was provided by the initial reporter: "the customer is reporting 2 subsequence erroneous results from an e18 observed and reported" "they ran 2 patient panels in duplicate the top analyzer read differently than the bottom" "no patient care provided based on erroneous results.".
Additional Manufacturer Narrative
The reported lot# 0356034 was not found for the reported catalog# 448416.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd phoenix¿ pmic-106 misidentified 2 results, with the top analyzer reading them differently than the bottom one.There was no indication of confirmatory testing, and results were not reported to clinicians.There was no report of patient impact.The following information was provided by the initial reporter: "the customer is reporting 2 subsequence erroneous results from an e18 observed and reported" "they ran 2 patient panels in duplicate the top analyzer read differently than the bottom" "no patient care provided based on erroneous results.".
Event or Problem Description
It was reported that the bd phoenix¿ pmic-106 misidentified 2 results, with the top analyzer reading them differently than the bottom one.There was no indication of confirmatory testing, and results were not reported to clinicians.There was no report of patient impact.The following information was provided by the initial reporter: "the customer is reporting 2 subsequence erroneous results from an e18 observed and reported.They ran 2 patient panels in duplicate the top analyzer read differently than the bottom."no patient care provided based on erroneous results.".
Additional Manufacturer Narrative
H.6 investigation summary this complaint is not confirmed.This complaint is for erroneous results due to mid ids when using phoenix panel pmic-106 (448416) batch number 0356034.The customer did not provide panel returns, isolates or lab reports for the investigation.The customer reported their "analyzer is now working normally after the fse corrected the issue.The mis ids was due to the malfunction that was corrected".Based on the follow up details provided by the customer, the panel batch in question is not considered to be defective.For further investigation, a review of quality notifications revealed no quality notifications generated on the complaint batches.A review of complaints revealed no additional complaints on the complaint batches.Complaint trending was performed, and no trends were identified associated with this defect.Based on the overall investigation performed, this complaint is unable to be confirmed for a panel issue.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Per baltrmphxidastaph rev 10 version h, id 6.0-6.11, indicates the potential risk of a misidentification was assessed as s4.

• Brand Name: BD PHOENIX¿ PMIC-106
• Common Device Name: FULLY AUTOMATED SHORT TERM INCUBATION AST
• 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: 12822031
• Report Number: 1119779-2021-01827
• Device Sequence Number: 12154689
• Product Code: LON
• UDI-Device Identifier: 30382904484164
• UDI-Public: 30382904484164
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K053241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

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: 448416
• Device Catalogue Number: 448416
• Device Lot Number: SEE SECTION H10
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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