MAUDE Adverse Event Report: BIOMÉRIEUX, INC INCUBATOR MOD LEFT W/RACKS 3D

Model Number 210159

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

An industry customer in the united states notified biomerieux of a false positive result in association with their bact/alert® incubator mod left w/racks 3d (ref.210159, serial # (b)(4)) when testing advanced therapy medical product (atmp).The customer stated two (2) ifa plus culture bottles were declared positive; however, when reviewing the bottle graphs the growth curves were flat.One (1) bottle was sub-cultured and gram-stained.The customer stated they may have observed gram-positive cocci; however, this was unconfirmed as no organisms were present on the gram slides.Biomérieux customer service has requested the bottle subculture results for both impacted bottles.As there is no patient associated with this sample, there is no adverse event related to any patient's state of health.Biomérieux will open an internal investigation for this report.

Manufacturer Narrative

Context: an industry customer in the united states notified biomerieux of a false positive result in association with their bact/alert® incubator mod left w/racks 3d (ref.210159, serial # (b)(6)) when testing advanced therapy medical product (atmp).Investigation: batch history record and complaint trend analysis: a bottle lot number query was performed in the trackwise digital (twd) database for lot number 0004100295.Four (4) complaints were returned on the search.One complaint is the one under this investigation, case (b)(4).The other three complaints are not related to high initial value threshold false positive results.The investigation concludes there is no adverse trend related to the bact/alert 3d for this complaint investigation.Investigation results: the data provided for the complaint included the observa® bottle graphs for the sample, and an instrument data backup made on 03dec2021.The investigator made the following conclusions: there is no evidence of the instrument contributing to the issue.The cell 2d60 had no other bottles with high reflectance.There were no instrument faults present that contributed to the issue.Bottle id (b)(4) was the only bottle contained in the backup that was flagged positive by the initial value threshold algorithm.Bottle id (b)(4) graph showed the reflectance was just over the threshold value used by the algorithm by a few points.The ifa plus bottle lot 0004100295 has no similar complaints, and is not yet expired.The customer did not check it for damage before use.The customer stated the bottle was not delayed in loading after inoculation.The customer stated the sample ph was 7.2, and the volume inoculated was 1 ml.The sample is cellular and does contain high white blood cell count, but the specific cell count is not shared.The subculture of the bottle was negative and the mate bottle was negative.Both bottle graphs were flat without signs of log phase growth.The root cause of the false positive result is most likely related to the high number of cells in the sample.No other probable root causes were revealed by the investigation.The investigator reviewed the bottle instructions for use (ifu) bact/alert® ifa plus document 056066- 01 - 2020-07 and finds guidance provided for storage, pre-usage inspection, handling of positives and limitations of test.The investigator concludes that the ifu provide adequate directions for the user.

• Brand Name: INCUBATOR MOD LEFT W/RACKS 3D
• Type of Device: INCUBATOR MOD LEFT W/RACKS 3D
• Manufacturer (Section D): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: justine gouvier ; 5 rue des aqueducs; craponne, MO 69290 ; FR 69290
• MDR Report Key: 13111082
• MDR Text Key: 290472733
• Report Number: 1950204-2021-00088
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026049577
• UDI-Public: 03573026049577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

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
• Device Operator: Health Professional
• Device Model Number: 210159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1