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

Model Number P612

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that a screw was loose on the pipettor of the cobas p 612 pre-analytical system.This caused the pipetting system to leak, in turn causing an unspecified number of sample aliquots to be diluted with water.The customer noticed the diluted aliquots and were aware that any results measured from the aliquots must be incorrect.The customer provided an example of one patient sample which had an erroneous result for potassium.The potassium value measured from an affected aliquot was 50 % different than the value measured from the primary tube.No adverse events were alleged.The potassium electrode lot number and expiration date were asked for, but not provided.There was a leakage in the dilutor valve.The field service engineer adjusted the dilutor valve and the issue did not recur.

Manufacturer Narrative

The customer provided another example of a patient sample affected by the issue.Refer to the attachment.The diluted aliquot tube of the sample was tested on an abl90 radiometer analyzer and values from this tube can be seen on the left side.The primary tube of the sample was also tested on the abl90 radiometer analyzer and values from this tube can be seen on the right side.As part of daily operation, the user is required to check the system for possible leakage prior to running the system.Due to missing this check, the leakage was not noticed.A warning label on the device also emphasizes the importance of checking the fluid system for leakage.

• 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
• MDR Report Key: 8045546
• MDR Text Key: 128261963
• Report Number: 1823260-2018-04110
• 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: 11/13/2018

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: P612
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1