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

Catalog Number 07962673001

Device Problem Mechanical Jam (2983)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer replaced the motor and sensor cable.He adjusted the work position sensor, stopper, and shifter air pressure.He performed a test run of tubes with recapping and aliquot and the p612 functioned normally.The investigation is ongoing.

Event Description

There was an allegation of a recapper error that prevented the analyzer from initializing.Upon investigation, the field service engineer found a slightly melted cable.

Manufacturer Narrative

The investigation determined the event was due to how the cable was routed as it came into contact with the motor and was slightly melted.The reported issue was resolved after replacing the motor and sensor cable.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17871080
• MDR Text Key: 324925815
• Report Number: 1823260-2023-03183
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

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 Catalogue Number: 07962673001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1