MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS® P 512 PRE-ANALYTICAL SYSTEM; LABORATORY PREANALYTICAL SYSTEM

Model Number P512

Device Problems Smoking (1585); Temperature Problem (3022)

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

Event Date 01/07/2024

Event Type  malfunction  

Event Description

We received an allegation that the cobas p512 pre-analytical system had burnt wires around the primary tube transport (ptt) after receiving alarms that there wasn't a tube in the ptt when there was.The field service engineer verified that there was no smoke or damage to the panels.The wiring around the ptt was scorched and frayed.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

Material for the investigation had been requested but could not be provided.The investigation did not identify a product problem.

• Brand Name: COBAS® P 512 PRE-ANALYTICAL SYSTEM
• Type of Device: LABORATORY 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: 18573615
• MDR Text Key: 333626794
• Report Number: 1823260-2024-00219
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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: P512
• Device Catalogue Number: 08484694001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/28/2024
• 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