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

Catalog Number	08454345001
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	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 5 patients' samples tested with elecsys estradiol assay on a cobas e801 immunoassay analyzer when compared to a different analyzer.Sample 1 (patient 1): initial result: >3000 pg/ml (accompanied by a data flag).1st repeat result: 47.4 pg/ml.2nd repeat result: 949 pg/ml.Sample 2 (patient 2): initial result: >3000 pg/ml (accompanied by a data flag).1st repeat result: 179 pg/ml.2nd repeat result: 915 pg/ml.Sample 3 (patient 3): initial result: >3000 pg/ml (accompanied by a data flag).1st repeat result: 275 pg/ml.2nd repeat result: 456 pg/ml.Sample 4 (patient 4): initial result: >3000 pg/ml (accompanied by a data flag).1st repeat result: 24 pg/ml.2nd repeat result: 253 pg/ml.Sample 5 (patient 5): initial result: >3000 pg/ml (accompanied by a data flag).1st repeat result: 23.7 pg/ml.2nd repeat result: 1259 pg/ml.The initial results of >3000 pg/ml (accompanied by a data flag) prompted the repeat of the samples.
Additional Manufacturer Narrative
The estradiol reagent lot number and expiration date were not provided.The alarm trace did not show any abnormality.The field service engineer (fse) found the measuring cell, the pinch valves, and the pinch tubing were compromised.He replaced the measuring cell, the pinch valves, and the pinch tubing.The fse verified the instrument by performing a blank cell calibration.The blank cell calibration passed.The customer performed calibration and qc and they were successful.The service actions (replacing the measuring cell, the pinch valves, and the pinch tubing) resolved the issue.No further issues were reported afterward.
Additional Manufacturer Narrative
The repeat results that were obtained from the other analyzer, were deemed to be correct.The root cause of the event was consistent with a wear issue.

• 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: 18210903
• Report Number: 1823260-2023-03762
• Device Sequence Number: 7401915
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 12/20/2023

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
• 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): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/20/2023
• 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 Age: 38 YR
• Patient Sex: Female