MAUDE Adverse Event Report: BIOMÉRIEUX, INC. PREVI ISOLA; PREVI® ISOLA

Model Number 29500

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of experiencing an issue in which a cps media plate was mislabeled as a pvx media plate in association with their previ® isola instrument (ref 29500, serial (b)(4) while using previ® isola zebra label roll (ref 416198, lot 515603).The customer was processing vaginal samples on pvx and anc media when they noticed that one of the pvx plates did not have a label attached to it.Later, while processing urine samples on cps media, the customer found a cps plate with a pvx label on it.The customer confirmed that the cps plate did not have two labels affixed (cps and pvx), but rather just one incorrect label.The customer did not know exactly where the mislabeled cps plate was in the series of urine samples that were processed.The customer also indicated that 7 or 8 vaginal samples were processed between the pvx plate without the label and the cps plate with the pvx label.Since the customer was concerned that the labels for the rest of the cps plates may have been shifted by one plate, the customer decided to manually reseed the rest of the urine samples.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 has been initiated.

Manufacturer Narrative

Biomérieux investigation was conducted in response to multiple customer complaints reported against 416198 (previ isola zebra label rolls) lots #515303 and #515603.The complaints indicate that the labels remain attached to the liner material, and are not released from the rolls and adhered to the plates during previ® isola processing.The investigation identified: 1.Material 416198 was not "storage controlled" during transit from idc/subsidiary/distributor warehouse to another idc/subsidiary/distributor.2.France idc does not monitor/maintain warehouse humidity.Despite this, the two (2) impacted lots (#515303 and #515603) were shipped worldwide, with the majority of the customer complaints originating in france.The root cause for 416198 labels randomly sticking to the roll liner could not be determined.There were no changes in manufacturing for the two (2) impacted lots (#515303 and #515603) since the release of the 416198 rev b on 23may2014, and no changes in the product vendor since 28oct2013.Material 416198 rev c was released on 12-jan-2021 with a new adhesive (fasson at2550).There has been no systemic issue with the new adhesive applied to the label roll.

• Brand Name: PREVI ISOLA
• Type of Device: PREVI® ISOLA
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11345147
• MDR Text Key: 252783565
• Report Number: 1950204-2021-00016
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/25/2021

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
• Device Operator: Health Professional
• Device Model Number: 29500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1