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

Model Number	CA 19-9 ELECSYS E2G
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	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined the potential for non-reproducible elevated results (i.E., "high flyers") when using this elecsys ca 19-9 reagent lot on the cobas e 801 analyzers.When performing multiple determinations from a single sample aliquot, this phenomenon is expressed as a non-reproducible elevated result when compared to the other results from the same sample aliquot.The increased frequency of non-reproducible elevated ca 19-9 results is not related to the cobas e 801 analyzers.Roche has provided a workaround for customers to repeat all results =37 u/ml.Instructions for implementing these workarounds were communicated to customers by customer notification.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ca 19-9 immunoassay on a cobas 8000 e 801 module (serial number (b)(4).The sample initially resulted in a ca 19-9 value of 35.0 u/ml with a flag and repeated as 399 u/ml with a flag.The 399 u/ml value was reported outside of the laboratory to the doctor.The result was questioned and the sample was repeated twice on (b)(6) 2022, resulting in values of 37.3 u/ml with a flag and 36.5 u/ml with a flag.A corrected report was issued.An additional repeat value of 37.6 u/ml from (b)(6) 2022 was also provided, but it is unknown if this value was provided in error or if it represents an additional repeat value from the sample.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15537962
• Report Number: 1823260-2022-03051
• Device Sequence Number: 14951694
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): N
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 05/31/2023
• Device Model Number: CA 19-9 ELECSYS E2G
• Device Catalogue Number: 07027028190
• Device Lot Number: 568976
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 84915
• Patient Sequence Number: 1
• Patient Sex: Unknown