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

Model Number CA 19-9

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).For ca 19-9 dilutions, product labeling states "samples with ca 19-9 concentrations above the measuring range can be diluted with diluent universal.The recommended dilution is 1:10 (either automatically by the analyzers or manually).The concentration of the diluted sample must be >50 u/ml." also, "note: the ca 19-9 antigen tends to aggregate.11 this may lead to non-linear dilution behavior in certain individual samples." the investigation is ongoing.Unique device identifier (udi) (b)(4).

Event Description

The initial reporter received questionable elecsys ca 19-9 immunoassay results for one patient tested on a cobas 8000 e 602 module.The patient's initial ca 19-9 result was reported outside the laboratory.The patient's physician asked for measurement of the patient's sample.Also, the customer performed repeat and dilution testing with the patient's sample due to the patient participating in a clinical trial with hematological malignancies.(b)(6).The e 602 module serial number was requested but not provided.

Manufacturer Narrative

The customer's calibration, qc, and sample pre-analytic data were requested but not provided.The patient's sample was provided for an investigation.The sample was tested on a lumipulse analyzer as well as a cobas 8000 e 602 module.Also, the investigation performed a protein a addition test and neuraminidase treatment test on the patient's sample.Refer to the attachment on the medwatch for the patient's results.The investigation confirmed the customer's ca 19-9 results.The investigation determined the patient's undiluted result and 1:2 diluted result were valid.Per product labeling, "the concentration of the diluted sample must be > 50 u/ml." the investigation determined the event was due to a sample specific issue.A product problem was not identified.For ca 19-9 dilutions, labeling states "note: the ca 19-9 antigen tends to aggregate.This may lead to non-linear dilution behavior in certain individual samples." updated medwatch field: d4, lot number and expiration date.

• Brand Name: ELECSYS CA 19-9 IMMUNOASSAY
• Type of Device: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11423430
• MDR Text Key: 268486798
• Report Number: 1823260-2021-00663
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• PMA/PMN Number: K050231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: CA 19-9
• Device Catalogue Number: 11776193122
• Device Lot Number: 502671
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1