MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number	07682913001
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results for 62 patient samples tested for elecsys tsh v2 (tsh), elecsys ft4 iv (ft4 iv), elecsys ige ii (ige ii), elecsys ft3 iii (ft3 iii) and elecsys t3 (t3) on a cobas 8000 e 801 module.The following are examples of discrepant results for 5 patient samples.Patient 1 initial ige ii result was 0.200 iu/ml.The repeat result was 337 iu/ml.Patient 2 initial t3 result was 0.553 ng/ml.The repeat result was 0.986 ng/ml.Patient 3 initial tsh result was 0.0734 uiu/ml.The repeat result was 1.38 uiu/ml.Patient 4 initial ft3 iii result was 0.6 pmol/l.The repeat result was 4.54 pmol/l.Patient 5 initial ft4 iv result was 0.259 ng/dl.The repeat result was 1.64 ng/dl.
Additional Manufacturer Narrative
The tsh reagent lot number was 90637101 with an expiration date of 28-feb-2027.The ft4 iv reagent lot number was 891745 with an expiration date of 30-sep-2026.The ige ii reagent lot number was 870196 with an expiration date of 30-nov-2026.The ft3 iii reagent lot number was 885874 with an expiration date of 31-oct-2026.The t3 reagent lot number was 893965 with an expiration date of 31-dec-2026.On (b)(6) 2026, salt deposits were identified on the incubator cover along with a hairline crack in the reagent pipette line.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) replaced valves, a reservoir, the liquid level detection (lld) sensor, and a sipper.Salt deposits were identified on the incubator cover and a droplet on the reagent tubing line.The fse replaced the tube.The instrument operated within specification.The investigation determined that a hairline crack in the reagent tubing line was the cause of the event.

• Brand Name: COBAS 8000 E 801 MODULE
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24621932
• Report Number: 1823260-2026-00955
• Device Sequence Number: 15993523
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 07682913001
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female