MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE REAGENT KIT

Catalog Number	01L75-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete sample id is (b)(6).All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated architect cyclosporine, which reportedly occurred on approximately 3 patients.The customer stated that the results were questioned, and samples were processed again with a new pretreatment set up, and result was lower.The customer provided the follow data for 1 patient: customer reference range is: 100.0 ng/dl to 400 ng/ml sample id (b)(6): on 12/18 initial result was 167.5, and repeat result was <30 and <30.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated architect cyclosporine, which reportedly occurred on approximately 3 patients.The customer stated that the results were questioned, and samples were processed again with a new pretreatment set up, and result was lower.The customer provided the follow data for 1 patient: customer reference range is: 100.0 ng/dl to 400 ng/ml sample id (b)(6): on 12/18 initial result was 167.5, and repeat result was <30 and <30.There was no reported impact to patient management.Update: additional information received: the customer reported that the issue was due to a human error with the preparation.
Additional Manufacturer Narrative
Additional information can be seen in section b5.
Event or Problem Description
The customer reported falsely elevated architect cyclosporine, which reportedly occurred on approximately 3 patients.The customer stated that the results were questioned, and samples were processed again with a new pretreatment set up, and result was lower.The customer provided the follow data for 1 patient: customer reference range is: 100.0 ng/dl to 400 ng/ml.Sample id (b)(6): on (b)(6), initial result was 167.5, and repeat result was <30 and <30.There was no reported impact to patient management.Update: additional information received: the customer reported that the issue was due to a human error with the preparation.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review, and device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Ticket trending review has not identified any related trends in which there was a product issue.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the architect cyclosporine reagent lot 55721fp00.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18470051
• Report Number: 1415939-2024-00002
• Device Sequence Number: 3100656
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2024

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: 07/16/2024
• Device Catalogue Number: 01L75-25
• Device Lot Number: 55721FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 02/12/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/11/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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: ARC I1000SR MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Sex: Unknown