MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® FA BLOOD CULTURE BOTTLE

Catalog Number	259791
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of a false negative result associated with the bact/alert® fa blood culture bottle (reference (b)(4)).The customer cultured blood from one patient into one (1) bact/alert fa and one (1) bact/alert fn bottle.The bact/alert fa bottle (bottle id arrhzhfd) produced a negative result and the bact/alert fn bottle (bottle id nrr0ppbx) produced a positive result.Both bottles were subcultured and both subcultures gave an identification of pseudomonas from vitek® ms instrument.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a false negative result associated with the bact/alert® fa blood culture bottle (reference 259791).The patient was on chemotherapy, but no further information was provided.The customer declined to provide a virtuo backup that includes the bottle readings.Two graphs for each bottle type were reviewed but it was not possible to thoroughly evaluate the data because raw readings were not provided.A virtuo screenshot showed bottle type fa plus bottle as negative and the bottle type fn plus bottle as positive.The manufacture records review could not be performed as the customer did not provide the lot number for the bact/alert® fa plus bottle type.The bact/alert® fa plus instructions for use (ifu), 9312050 e -2016-04 was reviewed showing it contains sufficient information regarding procedures and precautions.No bottles were requested to be returned as a result of this investigation as the customer sub-cultured the inoculated bottles.Visual inspection was not performed on retained bottle samples since the complaint was not about visual aspects of the product.Insufficient information was provided, potential causes of the false negative result in the bact/alert® fa plus bottle are delayed entry, insufficient sample volume, and antimicrobial therapy.There were no other false negative or sample related complaints associated with bact/alert® fa plus bottle type.A historical review of the last year's data found no other similar complaints.

• Brand Name: BACT/ALERT® FA BLOOD CULTURE BOTTLE
• Common Device Name: BACT/ALERT® FA BLOOD CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7884866
• Report Number: 3002769706-2018-00186
• Device Sequence Number: 19455074
• Product Code: MDB
• UDI-Device Identifier: 03573026055820
• UDI-Public: 03573026055820
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K020813
• 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,Followup
• Report Date (Section B): 03/15/2019

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 Catalogue Number: 259791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1