MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 111 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	C111
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of the fire has not been identified.The preliminary investigation identified issues with the outlets in the laboratory h3 other text : na.
Event or Problem Description
The customer alleged that on (b)(6) 2023, sometime around 11 a.M.The cobas c111 analyzer caught on fire.No injury was alleged and no damage to other equipment or surroundings in the laboratory was reported.
Additional Manufacturer Narrative
Section d8 was updated.This event occurred in ecuador.According to the inspection report which was conducted by an external party, the laboratory socket where the instrument was connected showed an incorrect wiring situation.As a further finding the laboratory was not designed to meet the requirements to operate as a laboratory.A thunderstorm was reported that evening.It is possible that an electrical charge as a result of the storm combined with the incorrect grounding system could have contributed to the event.The customer disposed of the instrument so it was unavailable for inspection by roche.With the information provided, the investigation concluded that the cobas c111 analyzer was not the cause of the fire.The cobas c111 analyzer conforms with international electrotechnical commission (iec) standards.

• Brand Name: COBAS C 111 ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16912011
• Report Number: 1823260-2023-01597
• Device Sequence Number: 6170450
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K063744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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 Model Number: C111
• Device Catalogue Number: 04528778001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/15/2023
• 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