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

Model Number P612

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer alleged that 2 times per day open sample tubes are "flying through¿and sometimes even outside" of the cobas p 612 pre-analytical instrument.The customer stated that the sample tubes are getting stuck behind one side of the laser - liquid level detection (lld) cover which was modified by the manufacturer in november 2016.The customer complains that, due to this issue, there is a high risk of contamination and infection.There is no allegation that an adverse event has occurred due to this issue.No questionable or erroneous results have been reported due to this issue.The field service engineer (fse) visited the customer site and found that the laser ¿ lld cover was a little loose.The fse tightened and adjusted the cover and checked positions.The fse performed a test run with no errors.The customer has not had any more problems and the instrument is operational.Based on the information available, a combination of factors caused the issue: the laser ¿ lld cover had not been placed correctly on the instrument and a rack had not been properly aligned.Investigations are ongoing.

Manufacturer Narrative

The fse revisited the customer site.The liquid level detection (lld) cover was dismantled and the lld laser was cleaned.The cover was put back on and positions were checked; folding jacks and the used racks were checked.The z-axis motor was replaced.The replaced z-axis motor was requested for investigation.The issue has not occurred since the z-axis motor was replaced.There has been no report of contaminated samples.No persons have been injured or infected due to the issue.

Manufacturer Narrative

The field service engineer (fse) also noted that the labels were not properly applied to the sample tubes.Additionally, the 75 position rack trays were not fully filled with hitachi racks while being processed.The improperly applied labels can cause the tubes to stick to the finger of the gripper.When a tube is stuck, there is a possibility that the tube collides with the laser- liquid level detection unit which causes the tube to tilt slightly while still attached to the gripper.The investigation determined that the root cause of the issue was the improperly placed labels on the sample tubes.The gripper fingers should be regularly cleaned which is addressed in product labeling.

Manufacturer Narrative

Manufacturing site was corrected.

• 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: 6576770
• MDR Text Key: 75527212
• Report Number: 1823260-2017-01034
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2017

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: P612
• Device Catalogue Number: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/28/2017
• Supplement Dates FDA Received: 05/31/2017; 06/19/2017; 12/08/2017
• 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