MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E601
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The elecsys hcg stat reagent lot number is 86901300, and the expiration date is 31-oct-2026.A field service engineer (fse) determined that the original sample was not available for rerun for investigation.A sample from the day after was available, and all of the results were high.Qc and a precision check were within specifications.The instrument was operational, and no additional errors have occurred.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys hcg stat result from the cobas 6000 e601 module for one patient.The initial result was 24 miu/ml, accompanied by a data flag.The repeat result was >10,000 miu/ml, accompanied by a data flag.Another sample was collected at the same time and had a result of 12996 miu/ml.The initial result was questioned because the customer noticed that the patient was pregnant and noticed the sample short alarm that accompanied the initial result.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
Qc was within range before the event.The alarm trace report shows sample short and abnormal sample aspiration alarms.These are consistent with poor pre-analytical handling.The investigation determined the issue was due to pre-analytical handling issues at the customer site.

• Brand Name: COBAS 6000 E601 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: 24551763
• Report Number: 1823260-2026-00829
• Device Sequence Number: 20249589
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/30/2026

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 Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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