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

Model Number P512

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The field service engineer determined one of the gas springs for the protective cover was defective.He determined the other spring couldn't hold the weight of the cover alone.He exchanged the springs for the input and output sorter.During the investigation it was determined when the protective cover is in the upright position, the protective cover collides with the laboratory's ceiling.The instrument is on adjustable feet.It was advised to ensure that the height of the ceiling is larger than the height of the instrument with the protective cover opened.

Event Description

The initial reporter complained in regards to a protective cover of the cobas p 512 pre-analytical system.During routine operation, the system provided an alarm regarding the input sorter.The operator lifted the protective cover and placed the cover in an upright position.The operator leaned over into the instrument to remove the sample causing the alarm, and the cover closed on the operators back.There was no serious injury to the operator due to the event.

• 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; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10408624
• MDR Text Key: 203125709
• Report Number: 1823260-2020-02001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/14/2020

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: 07/17/2020
• Initial Date FDA Received: 08/14/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1