MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER

Catalog Number 03245233001

Device Problem Circuit Failure (1089)

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

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

The customer changed the probes on the analyzer, but this did not resolve the issue.The field service engineer found burn marks on the printed circuit board (pcb).He found the previous probe connection was leaking and caused corrosion, which led to a short-to-ground and the board burning one of the connector pins.The investigation is ongoing.

Event Description

There was an allegation of analyzer alarms and a burnt component on the cobas integra 400 plus analyzer.The customer alleged there was a burning smell but did not see any signs of burn marks and no smoke.

Manufacturer Narrative

The investigation found the operator did not screw the probe in place correctly.The field service engineer replaced the printed circuit board (pcb) transfer head module and tightened the probe.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS INTEGRA 400 PLUS ANALYZER
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17816617
• MDR Text Key: 324238239
• Report Number: 1823260-2023-03092
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K951595
• 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: 10/06/2023

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: 03245233001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/06/2023
• 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