MAUDE Adverse Event Report: ACCELERATE DIAGNOSTICS ACCELERATE PHENOTEST BC KIT

Model Number	10102018
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the accelerate phenotest bc kit allegedly had an incorrect result of methicillin-resistant s.Aureus (mrsa) and the patient's central line was removed and a new central line was inserted.The customer stated that testing on the bd phoenix identified s.Epidermidis.The incorrect result has not been confirmed.
Additional Manufacturer Narrative
A device evaluation is anticipated but not yet complete.Upon completion, a supplemental report will be filed.

• Brand Name: ACCELERATE PHENOTEST BC KIT
• Common Device Name: ACCELERATE PHENOTEST BC KIT
• Manufacturer (Section D): ACCELERATE DIAGNOSTICS; 3950 s country club road #470; tucson AZ 85714
• Manufacturer (Section G): ACCELERATE DIAGNOSTICS; 3950 s country club road #470; tucson AZ 85714
• Manufacturer Contact: laurie sang ; 3900 s country club road #470; tucson, AZ 85714 ; 6023187012
• MDR Report Key: 16820984
• Report Number: 3010671651-2023-00001
• Device Sequence Number: 6820239
• Product Code: PRH
• UDI-Device Identifier: 00862011000369
• UDI-Public: 00862011000369
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: 10102018
• Device Catalogue Number: 10102018
• Device Lot Number: 5793A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female