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

Catalog Number	08454345001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ferritin (ferritin) results from three patient samples tested on the cobas e 801 analytical unit.The reporter found qc errors on several assays prompting the rerun of the patient samples.Sample 1 the initial result was reported outside of the laboratory.The initial result was 26.5 ng/ml.The repeat result was 150 ng/ml.The repeat result was deemed correct.  sample 2 the initial result was <0.5 ng/ml.The repeat result was 25 ng/ml.Sample 3 the initial result was <0.5 ng/ml.The repeat result was 47 ng/ml.
Additional Manufacturer Narrative
The reagent lot number is 65213901.The expiration date is 31-dec-2023.The field service engineer (fse) inspected the analyzer and found the prewash aspiration nozzle obstructed.He then removed the blockage from the nozzle and decontaminated the tube.The fse stated that the blockage of the nozzle was consistent with the customer's infrequent performance of the prewash liquid flow cleaning (lfc) system maintenance task.Product labeling states "maintenance as required on the e 801 module - cleaning the ecl (electrochemilluminescence) and pre-wash flow paths of the e 801 module.If the number of measurements performed for each flow path exceeds the values listed below, the instrument issues an alarm.Then you must clean the ecl flow paths and the pre-wash flow path." the customer performed calibrations and qcs with successful results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the 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: 18267102
• Report Number: 1823260-2023-03861
• Device Sequence Number: 7691210
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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
• Report Date (Section B): 12/05/2023

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: 05/11/2023
• Initial Report FDA Received Date: 12/05/2023
• 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 Sex: Unknown