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

Catalog Number	03039773190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and expiration dates were not provided.The field service engineer checked the analyzer and found the probe was loose due to incomplete maintenance actions by the customer.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable cholesterol gen.2 results from the cobas integra 400 plus.The samples were repeated at the same laboratory and then at another laboratory.Sample 1 initial result was 0.37 mmol/l with a data flag.The repeat results were 3.21 mmol/l and 6.40 mmol/l.Sample 2 initial result was 0.01 mmol/l with a data flag.The repeat results were 3.21 mmol/l and 4.60 mmol/l.Sample 3 initial result was 9.23 mmol/l with a data flag.The repeat results were 5.20 mmol/l and 4.86 mmol/l.Sample 4 initial result was 15.73 mmol/l with a data flag.The repeat results were 5.20 mmol/l and 6.56 mmol/l.Sample 5 initial result was 11.26 mmol/l with a data flag.The repeat results were 5.20 mmol/l and 4.61 mmol/l.

• Brand Name: COBAS INTEGRA 400 PLUS 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; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 19350570
• Report Number: 1823260-2024-01500
• Device Sequence Number: 12613231
• Product Code: JJE
• UDI-Device Identifier: 04015630918430
• UDI-Public: 04015630918430
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• PMA/510(K) Number: K031824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 03039773190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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