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

Catalog Number	07027028190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ca 19-9 assay results from one sample from the sample patient tested on the cobas e 801 analytical unit.The reporter stated that the patient's results from (b)(6) 2024 were consistently <10 u/ml.They noticed the results started to increase in (b)(6) 2024.On (b)(6) 2024, the initial result of the initial patient sample was 80.5 u/ml.On (b)(6) 2024, the repeat result was 88.4 u/ml.The patient then went to another laboratory that uses a beckman analyzer.The result of the patient sample in this laboratory was 4.0 iu/ml.The initial patient sample was also sent to another laboratory for verification: on (b)(6) 2024: the repeat result from the diasorin analyzer with chemiluminescence as the laboratory method was 7 u/ml.The repeat result from the vidas analyzer that uses the enzyme-linked fluorescent assay (elfa) laboratory method was 7 u/ml.The reporter complained that all the competitor results were in the normal range and only the results from the analyzer were pathological and increasing.
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The patient sample was received for investigation.The investigation reviewed the calibration data and qc.The results were within specifications.The investigation reviewed the alarm trace.No issues were noted.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation confirmed the customer¿s ca 19-9 result.The investigation confirmed the presence of an interferent (high molecular weight heterophilic antibodies) in the patient sample using a heterophilic blocking tube (hbt).The investigation determined that the interferent (high molecular weight heterophilic antibodies) had caused the event.The investigation did not identify a product problem.

• 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: 20292974
• Report Number: 1823260-2024-02758
• Device Sequence Number: 8012464
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 10/29/2024

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: 08/31/2025
• Device Catalogue Number: 07027028190
• Device Lot Number: 75901802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/29/2024
• 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