MAUDE Adverse Event Report: BIOMERIEUX, S.A. PREVI COLOR GRAM

Catalog Number 29551

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of a problem associated with the previ® color gram.The customer reported seeing smoke coming from the previ® color gram on (b)(6) 2016.Once the previ® color gram was unplugged, the smoke stopped.A fire extinguisher was not used and no injuries occurred.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: the instrument was received in very poor condition.The outside of the instrument was covered in stains.Dried reagent material was coming out from the bottom of the instrument.Inside the instrument, there is remnants of reagent material, spills left behind , the bowl drain hole was clogged and corrosion on the main pcb board.These observations showed signed of internal flooding from the bowl.The supplier performed some additional testing, by checking the nozzle holders, solenoids, and internal tubing but found no leaks.The pumps were also checked but found no leaks.The cause of the reagent leak did no come from an internal system inside the instrument.The location of the smoke was found and came from a connector on the main pcb.The cause of this smoked connector was from corrosion build up caused by the fumes from the reagents leaked inside the instrument.The leak of the reagent came from the clogging of the bowl drain.The investigation shows a misuse of the instrument and a lack of maintenance.There has been no cleaning up of any spills.The preventive maintenance chart provided in the user manual must be followed.As written in §6-3 of the user manual (4501-1689), in case of stain leaks out of instrument, the user have to be sure the drain outlet (inside the strainer bowl) is not blocked by any foreign material.The system itself is not the root cause of the issue.

• Brand Name: PREVI COLOR GRAM
• Type of Device: PREVI COLOR GRAM
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6120306
• MDR Text Key: 60692963
• Report Number: 3002769706-2016-00485
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 29551
• Device Lot Number: 29551111839
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1