MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA; AUTOMATED PREANALYTICAL SYSTEM

Model Number MPA

Device Problems Melted (1385); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During routine operation, the customer experienced error messages, a burning smell, and smoke coming from the automated centrifuge unit of the analyzer.The customer did not see any physical damage but stopped using the analyzer.There was no adverse event and no one had to evacuate the laboratory due to the smoke.The field service representative found there was a mechanical failure of the temperature control unit and found melted plastic from overheating connectors in the condenser of the centrifuge unit.He replaced the temperature control unit and verified the system was operating as required.

Manufacturer Narrative

A specific root cause could not be identified.A query for similar cases was performed, but no other complaints were found.

• Brand Name: MPA
• 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: 6701838
• MDR Text Key: 80079470
• Report Number: 1823260-2017-01442
• 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: 09/05/2017

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: MPA
• Device Catalogue Number: 05005264001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 06/27/2017
• Supplement Dates FDA Received: 09/05/2017
• 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