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	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ferritin reagent lot number was 730731 with an expiration date of 30-sep-2024.The vitamin b12 ii reagent lot number was 740845 with an expiration date of 30-apr-2025.The vitamin d total iii reagent lot number was 744661 with an expiration date of 31-may-2024.The qc data provided shows a sudden shift to low results between (b)(6) 2023.On (b)(6) 2023 the field service engineer (fse) performed an instrument check which failed.The fse replaced the sample and reagent seals and checked all fluidic connections.The instrument check passed.The instrument was operating within specification.The investigation determined leakage inside the fluidic system (an issue with the syringe seals) was the cause of the event.
Event or Problem Description
The initial reporter questioned the results for multiple patient samples and multiple assays on a cobas e 801 analytical unit.Of the data provided for 9 patient samples, discrepant results were identified for 7 patient samples tested for elecsys ferritin (ferritin), elecsys vitamin b12 ii (vitamin b12 ii) or elecsys vitamin d total iii (vitamin d total iii).The units of measure for ferritin and vitamin d total iii were not provided.Patient 1 initial ferritin result was 18.The repeat results were 315 and 320.Patient 2 initial vitamin b12 ii result was < 100 pg/ml.The repeat results were 551 pg/ml and 517 pg/ml.Patient 3 initial ferritin result was 369.The repeat results were 628 and 652.Patient 4 initial vitamin d total iii result was 22.The repeat result was 65.7 patient 5 initial vitamin d total iii result was 61.2.The repeat result was 25.8.Patient 6 initial vitamin d total iii result was 31.1.The repeat result was 151.Patient 7 initial vitamin b12 ii result was 330 pg/ml.The repeat result was 0.992 pg/ml.

• 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: 18415770
• Report Number: 1823260-2023-04196
• Device Sequence Number: 15415714
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 12/28/2023

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: 12/19/2023
• Initial Report FDA Received Date: 12/28/2023
• 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