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

Catalog Number	07682913001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insulin reagent lot is 90689200, the ige reagent lot number is 87019600, and the pth reagent lot number is 87530100.The expiration dates were not provided.The calibration and qc recovery data prior to the event was within specification.The field service engineer (fse) found a leak at the prewash valve assembly and repaired it.The service maintenance actions performed by the fse resolved the issue.
Event or Problem Description
There was an allegation of questionable results for multiple patient samples on a cobas 8000 e 801 module.The customer provided examples of discrepant results for 4 patient samples tested for elecsys insulin, elecsys pth, and elecsys ige ii.The customer stated that their moving average indicated an issue and was also having qc issues, which prompted them to repeat the patient samples.Sample 1 had an initial pth result of 8.26 pg/ml.The repeat result was 102 pg/ml.Sample 2 had an initial pth result of 11.8 pg/ml.The repeat result was 106 pg/ml.Sample 3 had an initial ige result of 182 iu/ml.The repeat result was 3510 iu/ml.Sample 4 had an initial insulin result of 0.7 uiu/ml.The repeat result was 7.33 uiu/ml.The repeat results were deemed correct.

• 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: 25098816
• Report Number: 1823260-2026-01776
• Device Sequence Number: 14722280
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/06/2026
• 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: Unknown