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

Model Number P 612

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).The event occurred in: (b)(6).

Event Description

The customer complained of an event on their cobas p 612 pre-analytical system where the patient results could have been impacted due to an open sample tube being dropped.A total of 65 patient samples were possibly contaminated.The customer drew new samples for all the possibly affected samples.No patients were adversely affected.No patient results were affected.No patients were given inappropriate treatment.The investigation is currently ongoing.

Manufacturer Narrative

The investigation determined that the problem was caused by operator error.The gripper had water inside it which was caused by the user not regularly emptying the condensation container.Water in the gripper would cause an improper force being applied by the piston which would cause the gripper finger to not function properly.

Manufacturer Narrative

More specific details of the event were provided by the customer.The customer stated that the sample sorter had a sample in its gripper and it tried to place the sample in a urgent rack.The sample wasn¿t released by the gripper, but the sorter thought the sample had been released and left in the sample rack.So when the sample gripper went to pick up the next sample it skimmed over the line 1 rack hitting every row full of samples which caused them all to spill and splash into one another.The force was strong enough to cause the samples to be splashed into the line 2 rack causing contamination of those samples too.It then dropped the sample at the back of the sorter as it went to pick the next sample up.

• 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: 7633269
• MDR Text Key: 112721561
• Report Number: 1823260-2018-02005
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2018

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: P 612
• Device Catalogue Number: 07563116001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 06/04/2018; 06/04/2018
• Supplement Dates FDA Received: 07/12/2018; 07/31/2018
• 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