MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT SN (PLASTIC) - 259790; BACT/ALERT® SN (PLASTIC) - 259790

Catalog Number	259790
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of experiencing recovery issues (negative results) in association with the bact/alert® sn bottle (ref 259790).The customer also reported this issue to the china competent authority (nmpa).The information received from the customer indicates that the customer is experiencing issues with the bact/alert sn bottles because the bottles do not contain resin and cannot absorb antibiotics.The customer also states that clinical patients have often taken antibiotics outside the hospital or other departments, resulting in the positive rate of the bottle to be low.The "procedural notes and precautions" section in the package insert for the bact/alert® sn bottles includes the following: "obtain blood samples prior to initiating antibiotic therapy.If this is not possible, draw blood immediately before administering the next antibiotic dose." the "limitations of the test" section of the package insert includes the following statement: "on rare occasions organisms may be encountered that grow in the bact/alert® sn culture bottle growth media but do not produce sufficient carbon dioxide to be determined positive.A factor that may lead to this situation is the presence of active antibiotics in a sample." according to local customer service (lcs) the customer will not provide information related to any patients and the customer has started using the bact/alert® fa plus and bact/alert® fn plus bottles.The fa plus and fn plus bottles contain resin.Since this issue was reported to a local competent authority by the customer, further review of this complaint according to local regulation/guidance is needed to determine reportability.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in china notified biomérieux of obtaining 'a low positivity rate' with the bact/alert® sn culture bottle (part number 259790).The customer was not able to provide a valid bottle lot or instrument serial number.The customer initially reported this incident to the local competent authority.The customer chose to use the bact/alert® sn bottle type, and did not adhere to the intended use, limitations of the test, procedural notes and precautions in the bottle's instructions for use (ifu) that could contribute to growth performance.A possibility for the root cause is that the customer obtained blood samples after initiating antibiotic therapy.If not possible to draw before therapy, then blood should had been drawn immediately before administering the next antibiotic dose.This would be the trough serum level concentration for the antimicrobial.The ifu states on rare occasions organisms may be encountered that grow in the bact/alert® sn culture bottle growth media but do not produce sufficient carbon dioxide to be determined positive.The five whys root cause analysis provided three probable root causes (sample volume, best bottle type for patient sample, and delay of bottle receipt for incubation).The investigator was unable to investigate as the customer could not provide additional information.Therefore, the specific root cause cannot be determined.Queries of manufacturing data for the sn bottle type and associated complaint data do not show evidence of any adverse trend for any issue related to sample recovery.Since the sn bottle lot number was not provided, review of the manufacturing records for bact/alert® sn culture bottle could not be performed.However, all lots released to the field met all quality control and release criteria.The following are possible root causes that can cause a false negative result in a bact/alert® sn culture bottle.It is possible that multiple root causes are contributing to the results.Under filling of the bottle with patient sample.¿ failure to use the correct bottle type for patients on antibiotic therapy.Failure to draw the blood culture at the trough serum concentration for the antimicrobial dose.Failure to run multiple blood culture samples as recommended by the clsi guidelines.Delayed entry and/or pre-incubation of the bottle prior to loading on instrument.Historical review of complaint data determined this is an isolated incident; there were no other related complaints associated with bact/alert® sn.The bact/alert® fan plus bottle type would be the correct bottle to use for patients on antibiotic therapy.The bact/alert® sn culture bottle was not specifically designed to neutralize these antimicrobials and could result in difficulty in recovery.Please note that the instructions for use (ifu) for all bact/alert blood culture bottle types state it is best to draw blood before the patient receives antimicrobial therapy.The customer did not provide sufficient information to analyze the frequency and causes of the sample recovery related issue in order to identify control/preventive measures to address the incident.The customer feedback in the complaint was that the customer began to use bact/alert® fan plus culture bottles that contain polymeric beads to adsorb antimicrobials.Customer service also provided the customer with links to the publications below (to better understand the use of adsorbent polymeric beads in bact/alert® fan plus media in comparison to standard media): bact/alert fan plus media brochure, bact/alert® fan plus ¿new plastic fantastic media¿ brochure, (english language, order number (b)(4)).Diane flayhart ¿comparison of bactec plus blood culture media to bact/alert® fa blood culture media for detection of bacterial pathogens in samples containing therapeutic levels of antibiotics¿ j clin micro 2007."evaluation of biomérieux bact/alert® polymeric bead-based fa plus and fn plus blood culture bottles for detection of bacteraemia" - r.Amarsy-guerle, h.Jacquier*, l.Raskine, f.Mougari, b.Berot, e.Cambau (paris, fr)."evaluation of bact/alert® fa plus and fn plus resin-based media for sepsis patients admitted to the emergency department, cancer centre and intensive care units" - d.H.Lee, s.J.Kim*, e.H.Koh, s.H.Lee (jinju, ulsan, kr).2016 bmx booklet: blood culture a key investigation for diagnosis of bloodstream infections (prn_16_0097a_00_mk_approved13jul16).The bottle type selection for blood culture testing at a clinical hospital is the decision of the hospital's medical director.There are many factors that may be used in the decision-making process for each facility (e.G.Patient population, epidemiology, specialty care, etc.).There is no evidence of any bottle malfunction with the bact/alert sn culture bottle.

• Brand Name: BACT/ALERT SN (PLASTIC) - 259790
• Common Device Name: BACT/ALERT® SN (PLASTIC) - 259790
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 11569145
• Report Number: 3002769706-2021-00003
• Device Sequence Number: 3621505
• Product Code: MDB
• UDI-Device Identifier: 03573026055813
• UDI-Public: 03573026055813
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021123
• 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): 07/26/2021

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: 259790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1