MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 512 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P512

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The field service engineer discovered a worn and damaged belt.He replaced the belt, and performed system adjustments.The investigation determined the service actions resolved the issue.

Event Description

The initial reporter complained of sample contamination during the sorting of sample tubes on a cobas p 512 pre-analytical system.The reporter stated during the sorting process, an open sample tube hit a rack, which caused serum to be splattered, and contaminated a sample two positions ahead.The customer observed this event, and removed the contaminated sample from the rack, and the pre-analytical system.The customer confirmed no erroneous results, or serious injuries occurred.

• Brand Name: COBAS P 512 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; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10641765
• MDR Text Key: 210185999
• Report Number: 1823260-2020-02469
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2020

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: P512
• Device Catalogue Number: 05083435001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/07/2020
• 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
• Patient Sequence Number: 1