MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; IMMUNOCHEMISTRY ANALYZER

Catalog Number 08454345001

Device Problems Mechanical Jam (2983); Non Reproducible Results (4029)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

On the morning of the event, qc was acceptable but it went out of range a few hours later.On 10-feb-2024 the field service engineer found that the washing wells were not working due to gear pump being without pressure.He replaced the gear pump head and installed new reagents on board.Different checks were performed and they were successful.Calibrations and qcs were performed and they were acceptable.The instrument was performing within specifications.The working hours of the affected gear pump head were requested but this information could not be determined.A further investigation of the affected part was not possible as it had already been disposed.The cause was traced to a component failure of the gear pump head.The service action (replacing the gear pump head) resolved the issue.

Event Description

We received an allegation about discrepant results for unspecified patients' samples tested on a cobas e 801 immunoassay analyzer.Discrepant results 1 patient sample tested with elecsys probnp assay, and elecsys troponin (tnt) assay, and 1 patient sample tested with folate (fol) assay, elecsys prostate-specific antigen total (tpsa) assay, and elecsys free prostate-specific antigen (fpsa) assay were provided.Sample 1: probnp: initial result: 901 mg/l.Repeat result: 3554 mg/l.Tnt: initial result: 153 ng/l.Repeat result: 74 ng/l.Sample 2: fol: initial result: 5.67 ng/ml.Repeat result: 3.22 ng/ml.Tpsa: initial result: 4.96 ng/ml.Repeat result: 6.51 ng/ml.Fpsa: initial result: 0.668 ng/ml.Repeat result: 0.993 ng/ml.The initial results were reported outside the laboratory.When the samples were re-tested, reportedly, all patients and treating physicians were then informed about the correct results.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18809667
• MDR Text Key: 337628169
• Report Number: 1823260-2024-00606
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1