MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® FN PLUS

Catalog Number 410852

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  malfunction  

Event Description

A customer in (b)(6) reported that a bact/alert® fn plus bottle cracked and leaked in the instrument.The bottle flagged positive at 0.98 days, and when it was unloaded on (b)(6) 2019 from the instrument, blood leakage was observed from a crack on the bottle.Blood came in contact with the gloved hand of the user who was also wearing a lab coat.The user followed the decontamination process.The lot (4051577) of bottles was checked with no other problems observed.The customer reported that the bacteria was successfully isolated from this positive bottle and identified as staphylococcus aureus.The patient had another bottle tested and the result was the same.There was delay of two days for reporting results which also delayed the correct antibiotic treatment.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated for a customer report that a bact/alert® fn plus bottle cracked and leaked in the instrument.One broken and leaking bottle was found inside the bact/alert® 3d instrument.Clear pictures of the broken part of the bottle were not provided by the customer as the impacted bottle was discarded.Pictures from the bact/alert® 3d instrument and screen shots were obtained.The customer indicated there was no specific harm or injury to any employee or the patient due to this incident.The customer indicated the positive bottle result was delayed by two days, thus delaying patient treatment.The reason for the two day delay was not clear based on review of complaint text.The investigation examined the bact/alert® fn plus lot 4051577 packaging inspections, including the quality acceptable quality limit inspection documentation, and all the results were within specification.Quality assurance subsequently released the lots for distribution to the field on 24aug18.300 retain bottles from lot 4051577 were visually inspected by the investigator for any evidence of broken bottles.There were zero bottles found to be broken.The information outlined in the bact/alert® fn plus instructions for use (ifu) instructs the users "prior to use, the bact/alert® culture bottles should be examined for evidence of damage or deterioration (discoloration).Bottles exhibiting evidence of damage, leakage, or deterioration should be discarded." a definitive root cause for this complaint could not be determined.It is probable that the bottle was dropped during transport to the lab; however, the customer did not report the bottle was dropped at any point so the true root cause cannot be confirmed.Plastic bact/alert bottles are break resistant, but if dropped it is possible for the bottle to crack on the bottom.Cracks may not leak until the bottle is heated after being loaded into the instrument, as heating can cause cracks to expand.Global customer service advises all bottles be examined for damage before loading in the instrument, in addition to the inspection before use.Trending identified no other broken bottle complaints for bact/alert® fn plus, lot 4051577 besides the complaint under investigation.No adverse trend was identified upon conclusion of this investigation.

• Brand Name: BACT/ALERT® FN PLUS
• Type of Device: BACT/ALERT® FN PLUS
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 8413284
• MDR Text Key: 138563232
• Report Number: 3002769706-2019-00006
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357917
• UDI-Public: 03573026357917
• Combination Product (y/n): N
• PMA/PMN Number: K121455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2019
• Device Catalogue Number: 410852
• Device Lot Number: 4051577
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1