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

Model Number P612

Device Problem Computer Software Problem (1112)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained that the cobas p 612 pre-analytical system failed to detect underfilled sample tubes which could impact patient results.The customer stated that they were using sample tubes that require a specific concentration and if they are not filled to the correct volume it could lead to erroneous results.There was no allegation of an adverse event.The investigation is ongoing.

Manufacturer Narrative

The printed text on the tubes caused the wrong liquid level detection.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• MDR Report Key: 8195699
• MDR Text Key: 131832878
• Report Number: 1823260-2018-05104
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

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
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1