MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I CA 125 II REAGENT KIT; TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Catalog Number	08P49-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported a 69 year old female patient, who did not have a previous diagnoses of cancer, underwent additional scans and testing due to falsely elevated alinity i ca125 ii and alinity i ca19-9xr results.The following information was provided: the patient has a family history of cancer and presented to her general practitioner in (b)(6) 2024 with unexpected weight loss.(b)(6) 2024: ca125 ii initial result = 731 u/ml.Ca19-9xr initial result = 4013 u/ml.(b)(6) 2024: ca125 ii initial result = 866 u/ml.Ca19-9xr initial result = 4209 u/ml.(b)(6) 2024: ca 125ii initial result was >1000.0 u/ml, repeat with dilution = 1153.9 u/ml, cobas result = 14.8 u/ml.Ca19-9xr initial result was >1200.00 u/ml, repeat with dilution = 2410.65 u/ml, cobas result = 19.2 u/ml.Due to the elevated results, the patient underwent an abdominal scan, ercp, gastroscopy with biopsy, colonoscopy, and an endometrial biopsy.No cancer or pathology was found during the additional testing.No further impact to patient management was reported.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8p32-30 has a similar product distributed in the us, list number 8p32-21/-31.
Event or Problem Description
Update: additional clarifying information was received from the customer: the additional testing and scans were completed after the initial results from (b)(6) 2024 were reported.(b)(6) 2024: cervical smear for cytology.(b)(6) 2024: g&c scope.(b)(6) 2024: endometrial biopsy.The dates of the other testing/scans are unknown.The details of the family history of cancer is unknown.No further impact to patient management was reported.
Additional Manufacturer Narrative
Section b5 describe event or problem was updated to include clarifying information that was provided by the customer on 26apr2024.An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Section b5 describe event or problem was updated to include additional patient information that was provided by the customer on 20may2024.An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
Additional patient information was received from the customer on 20may2024: routine biochemistry (calcium and lft) and immune screen testing was completed.The results were not shared by the customer.No further/additional procedures were performed.There was no information available about the patient¿s diet and cause of the weight loss.Additionally, it was documented that the patient is not frail.No further impact to patient management was reported.
Event or Problem Description
The customer reported a 69 year old female patient, who did not have a previous diagnoses of cancer, underwent additional scans and testing due to falsely elevated alinity i ca125 ii and alinity i ca19-9xr results.The following information was provided: the patient has a family history of cancer and presented to her general practitioner in (b)(6) 2024 with unexpected weight loss.(b)(6) 2024: ca125 ii initial result = 731 u/ml.Ca19-9xr initial result = 4013 u/ml.(b)(6) 2024: ca125 ii initial result = 866 u/ml.Ca19-9xr initial result = 4209 u/ml.(b)(6) 2024: ca 125ii initial result was >1000.0 u/ml, repeat with dilution = 1153.9 u/ml, cobas result = 14.8 u/ml.Ca19-9xr initial result was >1200.00 u/ml, repeat with dilution = 2410.65 u/ml, cobas result = 19.2 u/ml.Due to the elevated results, the patient underwent an abdominal scan, ercp, gastroscopy with biopsy, colonoscopy, and an endometrial biopsy.No cancer or pathology was found during the additional testing.No further impact to patient management was reported.Update: additional clarifying information was received from the customer: the additional testing and scans were completed after the initial results from (b)(6) 2024 were reported.(b)(6) 2024: cervical smear for cytology.(b)(6) 2024: g&c scope.(b)(6) 2024: endometrial biopsy.The dates of the other testing/scans are unknown.The details of the family history of cancer is unknown.No further impact to patient management was reported.Additional patient information was received from the customer on 20may2024: routine biochemistry (calcium and lft) and immune screen testing was completed.The results were not shared by the customer.No further/additional procedures were performed.There was no information available about the patient¿s diet and cause of the weight loss.Additionally, it was documented that the patient is not frail.No further impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing of a retained reagent kit lot 56750fp00.Additionally, testing of returned human serum sample was completed.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A search for similar complaints did not identify an increase in complaint activity for lot 56750fp00.Ticket trending review did not identify any trends for the issue for the product.Device history review did not identify any non-conformances, deviations, or potential non-conformances with lot 56750fp00 and the complaint issue.In-house accuracy testing was completed on retained kits of reagent lot number 56750fp00.Validity and acceptance criteria were met, which indicates acceptable product performance.Return sample testing was performed on a customer returned human serum sample.The testing showed an interferent was present in this sample resulting in the alinity i ca 125 ii over-recovering relative to roche and other clinical findings.The effect was mitigated via peg precipitation for the ca125, suggesting the presence of a high molecular weight protein or antibody interferent.The patient was not diagnosed with either pancreatic cancer or ovarian cancer, prior to testing at customer site and no cancer or pathology was found during the additional testing.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i ca125ii reagent lot 56750fp00 was identified.

• Brand Name: ALINITY I CA 125 II REAGENT KIT
• Common Device Name: TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19176985
• Report Number: 3002809144-2024-00127
• Device Sequence Number: 19765029
• Product Code: LTK
• UDI-Device Identifier: 00380740131050
• UDI-Public: (01)00380740131050(17)240731(10)56750FP00
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042731
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 08P49-30
• Device Lot Number: 56750FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 05/20/2024; 06/28/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/14/2024; 06/09/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I CA 125 II RGT 1, 08P49-30, (B)(6) ; ALNTY I CA 125 II RGT 1, 08P49-30, (B)(6) ; ALNTY I CA 125 II RGT 1, 08P49-30, (B)(6) ; ALNTY I CA 125 II RGT 1, 08P49-30, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 69 YR
• Patient Sex: Female