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 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Component code - device subassembly = plug/fuse assembly.

Event Description

The customer stated the main power supply failed on the cobas p 612 pre-analytical system.The field service engineer (fse) was at the customer site when the analyzer shut down during operation and would not turn on.The fse stated the cobas p 612 was used for eight hours, powered off for four hours, and then had been in use for approximately one hour when the failure occurred.The fse found the power cord was partially melted and the power supply was damaged.The fse determined the cause was a failed power interface plug/fuse assembly.The fse replaced the power interface and cord with no issues.The unit powered on correctly.The fse confirmed that no one was injured and patient results were not affected.There was no allegation of an adverse event.

Manufacturer Narrative

The investigation determined that the portion of the plug that was melted was the end that was within the instrument and not where the user would hold the pug to either insert or remove it.

Manufacturer Narrative

Further investigation of the issue found the power entry module is not compatible with the fuse and the power dissipation for the fuse is higher than what is recommended by the power entry module manufacturer.The fuse's higher power dissipation can cause the melting of the power entry module and 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 of this material to catch fire.No lab personnel was injured.In order to prevent failure ensure the device does not exceed the recommended run time of 6 hours, switch off the system every day, or ensure that the device does not exceed the recommended operating temperature of 30°c as instructed in the product labeling.

• 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: 7007270
• MDR Text Key: 92496517
• Report Number: 1823260-2017-02553
• 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,Followup,Followup
• Report Date: 02/05/2018

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
• 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: 10/20/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 10/20/2017; 10/20/2017
• Supplement Dates FDA Received: 01/02/2018; 02/05/2018
• 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