MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE REAGENT KIT

Model Number	1L75-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased architect cyclosporine results on one (b)(6) male patient samples.The results provided were: on (b)(6) 2022 sid (b)(6) =198.4 ng/ml.On (b)(6) 2022 sid (b)(6) = 235.8 ng/ml.On (b)(6) 2022 sid (b)(6) =121.0 ng/ml.The physician concerned of cyclosporine result on (b)(6) 2022 lower compare to previous results without changing any medication.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation 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 architect cyclosporine reagent lot 25039m800.The ticket search determined that there is normal complaint activity for the likely cause lot.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.A specificity testing was performed on internal cyclosporine panels with a retained kit of lot 25039m800.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect cyclosporine reagent lot 25039m800.

• Brand Name: ARCHITECT CYCLOSPORINE REAGENT KIT
• Common Device Name: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; 433331157
• MDR Report Key: 13585894
• Report Number: 1415939-2022-00010
• Device Sequence Number: 17563122
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080751
• 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,Followup
• Report Date (Section B): 03/16/2022

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: 02/09/2022
• Device Model Number: 1L75-25
• Device Catalogue Number: 01L75-25
• Device Lot Number: 25039M800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Age: 30 YR
• Patient Sex: Male