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

Catalog Number 03245233001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The initial reporter stated they were having issues with their cobas integra 400 plus analyzer.They received a hardware error indicating an issue with the fluid controller and the customer observed that a probe had pierced into an aliquot tube.The customer tried changing probes, but received errors.The customer also tried cycling power to the instrument.During their troubleshooting, the customer noticed they received questionable results for approximately 3 patient samples.Data was provided for one patient sample with discrepant sodium electrode results.No questionable results were reported outside of the laboratory.The sample initially resulted in a sodium value of 133 mmol/l with a data flag.The customer decided to repeat the sample due to the errors they received and it repeated with a value of 144 mmol/l.

Manufacturer Narrative

The integra 400 plus analyzer serial number is (b)(6).The customer replaced the electrodes.The investigation is ongoing.

Manufacturer Narrative

The calibration performed on (b)(6) 2024 had errors.Re-calibration was acceptable and there were no further errors.Quality controls showed several data points outside of range.This is an indication of a reagent performance issue.Upon review of the alarm trace, a fluid hardware controller alarm and a "z-transfer controller" hardware alarm were observed.The field service engineer determined the probes were descending too far into the wash station as the transfer head failed.The transfer head assembly was replaced.Controls were acceptable and no further alarms occurred.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 46250-0457
• MDR Report Key: 18818745
• MDR Text Key: 336886276
• Report Number: 1823260-2024-00629
• 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: 03/25/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03245233001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male