MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ACTH; ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM

Catalog Number	07026684190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There is a suspected interference with the elecsys acth assay due to questionable results for 1 patient on a cobas e 801 analytical unit.On 15-jun-2022 the initial result was > 2000 pg/ml.The repeated result was 39480 pg/ml following a dilution.On 15-sep-2022 the initial result was > 2000 pg/ml.The repeated result was 29000 pg/ml following a dilution.On 10-mar-2023 the initial result was > 2000 pg/ml.The repeated result was 61050 pg/ml following a dilution.On 28-jul-2023 the initial result was > 2000 pg/ml.The repeated result was 7375 pg/ml following a dilution.On 16-jan-2024 the initial result was > 2000 pg/ml.The repeated result was 71850 pg/ml following a dilution.The sample was tested using the siemens immulite method with multiple dilutions and the results were high.The numeric results were not provided.The repeated results were believed to be correct.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The customer noted that a heterophile antibody interference had been ruled out.The field service representative checked all probes, adjustments, pressures, and levels.He performed mechanism checks and instrument checks successfully.The investigation is ongoing.
Additional Manufacturer Narrative
Section d4 lot number was updated.A reagent lot number was provided for the alleged results that occurred on (b)(6) 2024.
Additional Manufacturer Narrative
It was noted that the customer's calibration signals were slightly higher than expected and the qc was above expected levels.Sample short alarms were observed in the system's alarm trace.The investigation did not identify a product problem.

• Brand Name: ELECSYS ACTH
• Common Device Name: ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19471990
• Report Number: 1823260-2024-01677
• Device Sequence Number: 15309345
• Product Code: CKG
• UDI-Device Identifier: 04015630939893
• UDI-Public: 04015630939893
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K060585
• 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,Followup
• Report Date (Section B): 08/07/2024

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: 07026684190
• Device Lot Number: 750778
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 07/20/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/27/2024; 08/07/2024
• 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