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

Model Number	02K4539
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely depressed architect ca125 ii results for a female patient diagnosed with ovarian cancer and being monitored for treatment efficacy while running on the architect i2000sr analyzer.The following data was provided (normal reference range for ca125: 35 u/ml or less): on (b)(6) 2022, sid (b)(4).Result: 23.40 u/ml due to the history of the patient at the testing center, it was discovered the patient¿s previous measurement generated a high value (july: result was around 740 u/ml) while the sample tested on august 10, 2022, was within the normal range.There was no impact to patient management reported.
Additional Manufacturer Narrative
Patient identifier: (b)(6) all available patient information is included.Additional patient details are not available.The complaint investigation for falsely depressed architect ca 125 ii results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search for lot 36655fp00 did not identify an increase in complaint activity related to the issue under review.A review of ticket trending data for the architect ca 125 ii (ln 2k45) was performed.No related trends were identified.This further investigation reviewed historical performance of reagent lot 36655fp00 was evaluated using worldwide data from customers in the field for architect ca 125 ii assay.The patient¿s data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 36655fp00 is within the established control limits.Therefore, no unusual reagent lot performance was identified for 36655fp00.The historical performance of the reagent lot using worldwide will be used in place of retained file sample analysis.The device history record review was performed on lot 36655fp00 which did not show any related potential non-conformances, deviations, or non-conformances related to the issue under review.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect ca 125 ii reagent lot 36655fp00 was identified.

• Brand Name: ARCHITECT CA125 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15440488
• Report Number: 3002809144-2022-00329
• Device Sequence Number: 5595124
• Product Code: LTK
• UDI-Device Identifier: 00380740145385
• UDI-Public: 00380740145385
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 11/17/2022
• Device Model Number: 02K4539
• Device Catalogue Number: 02K45-39
• Device Lot Number: 36655FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: ARC I2K PROC MOD, 03M74-01, ISR62208
• Patient Sex: Female