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

Catalog Number	08454345001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's plasma sample tested with elecsys probnp assay on a cobas e801 immunoassay analyzer when compared to a different cobas e801 immunoassay analyzer.Initial result: 48.3 pg/ml.The customer stated that the instrument gave an alarm for an abnormal low signal detected.Repeat result: 2790 pg/ml.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The probnp reagent lot number and expiration date were not provided.The customer indicated they had reset the system and had an abnormal measuring cell condition alarm.The field service engineer found that the pinch valves/tubing were faulty.He replaced the pinch valves and the tubing.He then ran measuring cell preparation 5 times.No further alarms were reported after the pinch valve replacement.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration was last performed on (b)(6)2023 and it was acceptable.Qc recovery was within ranges on the date of the event.No indication of a performance issue with the reagent.The alarm trace showed multiple alarms including abnormal aspiration (sample probe) alarms which is consistent with a preanalytical issue.It also showed low signal alarms and incubator bath water level sensor alarms.The root cause was due to faulty pinch valves/tubing.The service actions (replacing the pinch valves and the tubing) resolved the issue.The customer performed calibration and qc and they were successful.No further issues were reported afterward.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• Common Device Name: 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: 18627554
• Report Number: 1823260-2024-00301
• Device Sequence Number: 20766329
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/05/2024
• 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