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 Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The field service engineer reported that the cobas p 612 pre-analytical system (p612) was not powering up.He determined that the power input was damaged and there was a blown main fuse.The ac input plug and fuse holder were melted.The engineer replaced fuses and a power entry module.Upon further inspection, it was determined that there was a blown transformer/"pdm".The system had no voltage at 35 volts.He checked the transformer which appeared open, so he replaced it and a rectifier.After this, the system still did not have voltage at 35 volts.He tried one other transformer/"pdm" part, but still was not successful.Both transformer/"pdm" parts were found not to be working.The engineer did further troubleshooting of the power supply and wiring.He disconnected a filter capacitor and voltage appeared at the terminal block.He tried the capacitors from the failed transformer/"pdm" parts, but there was no success.He tried a capacitor from a working system and the voltage was restored at 35 volts.He stated that the voltage selector was missing from the power module connection.He replaced the "pem" and voltage selector.The system successfully initialized and he ran samples.The system was found to be operational.No adverse events were alleged.

Manufacturer Narrative

The affected parts were requested, but not provided for investigation.It is believed that the root cause is related to incorrect installation of the system.Based on all available information, there is no indication of a product malfunction.The issue was solved by the service actions.

Manufacturer Narrative

Manufacturing site was corrected.

• 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: 6440533
• MDR Text Key: 71213028
• Report Number: 1823260-2017-00660
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2017

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: P612
• Device Catalogue Number: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided; 03/10/2017
• Supplement Dates FDA Received: 06/27/2017; 12/08/2017
• 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