MAUDE Adverse Event Report: BIOMERIEUX, INC. BACT/ALERT® 3D INSTRUMENT

Model Number	200290
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
Event or Problem Description
A customer in (b)(6) notified biomérieux of false positive results associated with bact/alert® 3d instrument.The customer reported that when the bottles flagged positive by the instrument the laboratory performed a subculture using bold macconkey, chocolate agar incubating the plates +/- co2 at 37°c for 48 h.The customer reported that the concerned bottles were unloaded and incubated further in the external incubator together with the subcultures.If there was no growth on the subculture after 48 hours, the laboratory inoculated another sample from the bottle and incubated it again for 48 hours.This step has been repeated until the end of the incubation time defined for the bottles (seven days).Patient results: delay in reporting results to the physician.The delay is considered from the first result release and to the final result.The customer reported false positive directly after the bottles have been flagged positive in bact/alert and corrected the result at the end of the incubation time, after performing subcultures.The first result released was positive and took almost six (6) days to release the final result as negative.The bact/alert results have been released to the physician, when the bottles were flagged positive.After having the subculture results, the customer informed the physician about the false positive results.There is no evidence regarding inappropriate patient treatment.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed with results as follows: backup review for bottle id [arrhwyft and arrhwygy] no backup was available therefore we cannot evaluate the false positive.Conclusion the backup was reviewed from the site, there were no bottle movements, fault / operator codes, or algorithm issues found with the instrument that caused the false positives to occur.The backup did show that the customer loaded multiple bottles (10 bottles) in the rack which could cause a drop in temperature; however temperature fault codes did not occur, therefore, loading multiple bottles can be ruled out as a root cause.To prevent possible temperature fluctuations, the customer should activate the cold bottle compensation filter (see 514483-8en1 setup and configuration version b.50) to alleviate potential false positives when loading and unloading in bulk.Currently, the backup shows this feature is disabled.The probable root cause is sample related as all known issues with the instrument have been reviewed and not determined to be the root cause of the false positives.Biomérieux recommends to review the best practices in the user manual 514818 appendix c to help prevent false positives with the instrument and sample.Also recommend to follow the ifu (instructions for use) when handling false positives.

• Brand Name: BACT/ALERT® 3D INSTRUMENT
• Common Device Name: BACT/ALERT® 3D INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7845491
• Report Number: 1950204-2018-00324
• Device Sequence Number: 13820224
• Product Code: MDB
• UDI-Device Identifier: 03573026047566
• UDI-Public: 03573026047566
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K903505
• 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): 12/03/2018

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 Model Number: 200290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1