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

Model Number P 612

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that the twin tube sensor cable connector on the cobas p 612 pre-analytical system (p612) was broken, the cable was burned, and it needed to be replaced.The customer was using the instrument to sort samples and was unable to aliquot.The p612 generated an error message that was reproducible.There was no allegation that an adverse event occurred.The field service representative inspected the cable and found that it was melted and had a small burn mark.He could not find a cause for the issue.He replaced the cable and the instrument initialized, passed basic checks without errors, and recognized sample tubes as designed.The customer ran the instrument afterward without errors.Investigation activities are ongoing.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.One of the wires in the connector looked as if it had been torn off.It also appeared someone had attempted to plug the connector into the wrong place, causing damage and a short circuit.The issue was resolved by the previous service activities.

• 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: 6586970
• MDR Text Key: 75816468
• Report Number: 1823260-2017-01082
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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: P 612
• Device Catalogue Number: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: 05/06/2017
• Supplement Dates FDA Received: 07/14/2017
• 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