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

Catalog Number	05349966001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-00428
• Device Sequence Number: 17228441
• Product Code: LXG
• UDI-Device Identifier: 04015630929078
• UDI-Public: 04015630929078
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 05349966001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown