MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P 612

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer stated the cobas p 612 pre-analytical system would not power on.The customer checked the plugs and power supply.The light switch is not lighting up green when the customer attempts to turn the system on.The uninterruptible power supply(ups)is powered on and the p612 system is plugged in.The instrument was taken out of service.The field service engineer (fse) visited the customer site and identified a blown fuse and a melted electrical plug.The fse replaced the power cable and the fuse.There were no injuries related to this issue.The power dissipation for the fuse is higher than what is recommended by the power entry module manufacturer.This can only happen when a p612 with double recapper is connected to a main voltage lower than 220 vac.In this case, the fuse¿s higher power dissipation can cause the melting of the power entry module.This leads to the melting of the socket connector of the power cord.The power entry module is made of self-extinguishing material (flammability class ul 94v-o).There is no risk that this material can catch fire.To prevent this failure, it is recommended to replace the power cable and the power entry module; ensure the device operates within specifications, not exceeding the 6 hours run time; switch off the system every day, not exceeding the operation temperature of 30 c as stated in product labeling.The issue has been verified.Workaround steps have been determined.The root cause was determined to be the under dimension of electrical components.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6829653
• MDR Text Key: 84009760
• Report Number: 1823260-2017-01851
• Device Sequence Number: 1
• Product Code: JQP
• 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
• Report Date: 08/30/2017

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: P 612
• Device Catalogue Number: 07563116001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/30/2017
• 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: N
• Patient Sequence Number: 1