MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9; CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM

Catalog Number	07027028190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).Field e1 initial reporter facility name: (b)(6) hospital.The customer's qc results were ok.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ca 19-9 results for 1 patient on a cobas e 801 analytical unit.The initial result was 788 u/ml.The result was reported outside of the laboratory.On (b)(6) 2024 a new sample was tested and the result was 14.80 u/ml.Considering that the ca 19-9 results decreased significantly over a 5-day period, and that the patient's tests during the hospital stay found no other abnormalities, the doctors questioned the results from (b)(6) 2024.The sample from (b)(6) 2024 was retested and the results were 15.90 u/ml and 16.20 u/ml.
Additional Manufacturer Narrative
The results that were initially reported came from 3 different samples instead of 2 samples.It was initially reported that "the sample from 20-mar-2024 was retested and the results were 15.90 u/ml and 16.20 u/ml." however, the result of 16.20 u/ml was obtained from another sample taken from the patient on 20-mar-2024.The customer's calibration was well within expectations.The investigation found that sample 1 had a suspended filament/fibrine clot, indicating compromised sample quality.Due to the limited information provided, no clear root cause for the issue was found.The available information suggests that the issue is consistent with a preanalytical handling issue since a foreign body was observed in sample 1.A general reagent problem was not observed, because the qc prior to the event was within ranges.

• Brand Name: ELECSYS CA 19-9
• Common Device Name: CARBOHYDRATE ANTIGEN (CA19-9) 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: 19125791
• Report Number: 1823260-2024-01190
• Device Sequence Number: 15516228
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K050231
• 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): 06/04/2024

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 07027028190
• Device Lot Number: 708245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/04/2024
• 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 Age: 51 YR
• Patient Sex: Female