MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA 19-9

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2021

Event Type  malfunction  

Manufacturer Narrative

There were no indications of instrument issues at the time of the discordant observations.All related quality control results were within the normal ranges.This discordance was only seen for this one patient and there are no previous results available for this patient.The warning statement in the instructions for use states: "warning the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values.The atellica im ca 19-9 assay is based on the 1116-ns-19-9 antibody available through agreement with fujirebio diagnostics, inc.Assays using antibodies other than 1116-ns-19-9 may give different results." the limitations section of the instructions for use states: "note do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." siemens continues to investigate.

Event Description

The customer observed discordant atellica im 1600 ca 19-9 results for one patient compared to an alternate method and the clinical picture.The discordant results were not reported to the physician.There are no reports that treatment was altered or prescribed due to the discordant atellica im ca 19-9 results.

Manufacturer Narrative

Mdr 1219913-2021-00406 was filed on (b)(6) 2021.August 2, 2021 - additional information: the customer had a sample that recovered 160 - 172 u/ml with atellica im 1600 ca 19-9 kit lot 489 but recovered <0.6 u/ml with an alternate ca 19-9 assay.When the sample was diluted 1/2, 1/4, and 1/8, recovery (139 - 186 u/ml) was in line with the undiluted valued.There is no indication of a cancer diagnosis with this patient.The patient has no known diseases and was not taking medications/supplements at the time their blood was drawn.The sample cannot be sent to siemens healthineers for evaluation due to china customs issues.The expected values section of the atellica im ca 19-9 instructions for use (ifu) (10995285, revision 03, 2019-07) indicates 3.7% of samples from normal patients recovered >37 iu/ml so a certain number of elevated results from normal patients can be expected for this assay.As stated in the limitations section of the atellica im ca 19-9 ifu: "warning: do not use the atellica im ca 19-9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of atellica im ca 19-9.Normal levels of atellica im ca 19-9 do not always preclude the presence of disease.Note: do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.The concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Ca 19-9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Therefore, it is important to use assay-specific values to evaluate quality control results." the cause of the discrepant results seen by the customer with this one sample when using atellica im 1600 ca 19-9 kit lot 489 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The customer is operational.No further action is needed.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM CA 19-9
• Type of Device: CA 19-9
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12252779
• MDR Text Key: 264316133
• Report Number: 1219913-2021-00406
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414598178
• UDI-Public: 00630414598178
• Combination Product (y/n): N
• PMA/PMN Number: K031393
• 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: 08/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995490
• Device Lot Number: 489
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR