MAUDE Adverse Event Report: BIOMERIEUX, INC. OBSERVA V4.05 HP RP5810 PC W10

Catalog Number 423153

Device Problem Computer Software Problem (1112)

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

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of a bottle id record being changed in association with observa® database management system software (ref.423153) and the bact/alert® 3d system ((b)(4)).Customer service troubleshooting noted the following: on (b)(6) 2020 @ 1803 -> bottle id patclh18 loaded under acc# =(b)(6).On (b)(6) 2020 @ 0900 -> bottle id patclh18 record changed to acc# =(b)(6) by user= bact/alert.During this timeframe on the (b)(4), record stated to change from acc# =(b)(6) to acc# =(b)(6) by dbms (database management system).Customer service obtained backups from the observa and (b)(4), as neither have user manipulation involved in this record change event (no user logged in from (b)(6) 2020 @ 2300 to (b)(6) 2020 @ 0900).Backup records indicate that the (b)(4) claimed the dbms changed the bottle record, but then the observa system indicates the user: bact/alert made the record change.The customer indicated that they had a cleaning crew on-site during the night that disconnected their lis middleware box.This is confirmed on the observa logs, which show there is a failed link transmission at 0200 on (b)(6) 2020.The next user logged in at 0900 and reconnected the lis middleware, as seen by logs showing an immediate transmission that is successful.Shortly after that time is when the bottle record is changed (acc#).Other note, customer stated that acc# =(b)(6) was never located on this observa system, but instead the other system back in (b)(6) 2020.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united states for a bottle id record being changed in association with observa® database management system software (ref.423153) and the bact/alert® 3d system (bta3d).A bact/alert bottle was loaded into the bta3d system with accession number w04702019141100.The customer indicated that the accession number was changed to t99992001769500 the next day.A review of bta3d audit trail showed the change event occurred from the observa® system.Further investigation determined that the user edited the accession field and when prompted to confirm the change, the user selected ¿no¿.Selecting ¿no¿ should have cancelled the change completely but due to the anomaly in observa® the change was forwarded to the bact/alert® 3d.System engineering and support (se&s) was able to reproduce the issue with observa® connected to a bact/alert® 3d.Observa® user manual (048389-01) states to verify botte re-association when assigning new accession numbers: "note: under certain, rare, time-sensitive circumstances, manual re-association of a bottle from one accession to a new accession in the data management screen may cause a bottle association error.As a result, the bottle will not be associated to either accession.After re-associating a bottle id with a different accession number, ensure that the bottle id has been correctly re-associated.Perform a search for the re-associated bottle to verify that it has been re-associated to the new accession number." the root cause of this event is device design.The software anomaly causes the observa® system to send an update bottle record event to the bta3d instrument when selecting ¿no¿ to a confirmation change dialog box.After considering the severity and probability of this issue, biomerieux has assessed the overall risk to be irrelevant.

• Brand Name: OBSERVA V4.05 HP RP5810 PC W10
• Type of Device: OBSERVA V4.05 HP RP5810 PC W10
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10468753
• MDR Text Key: 246656126
• Report Number: 1950204-2020-00153
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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 Catalogue Number: 423153
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1