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

Model Number P612

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained that the tube sealer temperature was too high on the cobas p 612 system and melted the top of a tube.The customer indicated the system produced an error indicating the sealing temperature was too high.The customer saw a plastic tube top melting and noticed a burning smell.The customer checked the tube sealer and found that the temperature was too high.He was able to run samples that did not require sealing.No adverse event occurred.The field service engineer (fse) visited the customer site and identified an electrical failure of the thermos switch.The thermos switch was replaced.The customer ran samples through the system and all tests passed.

Manufacturer Narrative

The customer stated they do not clean the recapping module as instructed in the maintenance section of the operator's manual.The recapping module is only cleaned by the field service engineer during preventive maintenance visits.The investigation stated that the lack of maintenance resulted in the thermo switch to overheat which caused the tube to melt.

• 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6088872
• MDR Text Key: 59463198
• Report Number: 1823260-2016-01751
• 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
• Report Date: 11/29/2016

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: P612
• Device Catalogue Number: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• 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