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

Model Number P612

Device Problems Overheating of Device (1437); Smoking (1585); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

The engineer replaced the ribbon cables, a printed circuit board, and an air pump.All positions were re-calibrated.All associated parts were cleaned and lubricated.Numerous samples were run to verify the proper operation of the unit.

Event Description

The initial reporter stated they received an unspecific error on the aliquot module of the cobas p 612 pre-analytics system.The reporter stated that the aliquot module would not move.The field service engineer determined there was no electrical connection to the aliquot module pipettor assembly.The ribbon cabling in the unit was slightly burned and a printed circuit board was determined to be compromised.

Manufacturer Narrative

The engineer's observations point to a component failure due to an electrical issue with flex cabling and a printed circuit board, however, no evidence was provided.A general inspection of the production documentation and specifications showed no abnormalities.Without the affected material, the issue could not be investigated further.After the replacement of the affected parts, the system works fine.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16089477
• MDR Text Key: 308358953
• Report Number: 1823260-2023-00014
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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: 07962673001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• 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
• Patient Sequence Number: 1