MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P (701) POST ANALYTICAL SYSTEM; AUTOMATED POST ANALYTICAL SYSTEM

Catalog Number 05349966001

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is field service engineer (fse).The investigation found a bolt broke off of the sliding door due to a broken weld; the bolt holds the counter weight of the door.The investigation is ongoing.

Event Description

We received an allegation of an issue with a cobas p 701 post-analytical unit.The field service engineer (fse) found the sliding door of the instrument was broken while installing the instrument at the customer site.

Manufacturer Narrative

The investigation determined the root cause of the issue was due to human error.The person assembling the door did not properly weld the bolt that holds the counter weight of the door.

• Brand Name: COBAS P (701) POST ANALYTICAL SYSTEM
• Type of Device: AUTOMATED POST ANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13562683
• MDR Text Key: 292485201
• Report Number: 1823260-2022-00428
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 04015630929078
• UDI-Public: 04015630929078
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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: 05349966001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 03/21/2022
• 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