MAUDE Adverse Event Report: BIOMERIEUX INC BACT/ALERT MP 419744; BACT/ALERT® MP ¿ 419744

Catalog Number	419744
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned to the manufacturer.
Event or Problem Description
A customer in the united kingdom notified biomérieux of obtaining false positive results in association with the bact/alert® mp (ref.419744, lot 1053687).The customer stated that after a recent preventive maintenance was performed, 17 bottles were flagged as positive; the bottles were subcultured, and eleven (11) were confirmed to be false positive.The customer confirmed there was no adverse patient impact due to the false positive results.Biomérieux will initiate an internal investigation.

• Brand Name: BACT/ALERT MP 419744
• Common Device Name: BACT/ALERT® MP ¿ 419744
• Manufacturer (Section D): BIOMERIEUX INC; 100 rodolphe street; durham NC 27712
• MDR Report Key: 9434453
• Report Number: 3002769706-2019-00132
• Device Sequence Number: 534096
• Product Code: MDB
• UDI-Device Identifier: 03573026506063
• UDI-Public: 03573026506063
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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: Health Professional
• Device Expiration Date: 05/14/2020
• Device Catalogue Number: 419744
• Device Lot Number: 1053687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1