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	07/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient identifier or demographic information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer identified falsely depressed architect cyclosporine results for one patient the following information was provided: patient history - dosage was 4 tablets, with results 90-110ng/ml for a duration of 10 years.Early (b)(6) 2021, dosage reduced to 3 tablets, results were approximately 50 ng/ml.The customer expected the results to be approximately 67-82 ng/ml.Late (b)(6) 2021 dosage increased to 4 tablets; result approximately 50 ng/ml.The customer expected the results to be 90-110 ng/ml.The patient is performing normally.
Additional Manufacturer Narrative
A review of tickets was performed for reagent lot number 22007m800.The ticket search determined that there is normal complaint activity for the reagent lot and issue (falsely depressed results).A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A retained reagent kit of lot number 22007m800 was tested to evaluate the performance of reagent lot 22007m800 with internal panels.Acceptance criteria were met, which indicated acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect cyclosporine reagent 22007m800 was identified.

• Brand Name: ARCHITECT CYCLOSPORINE REAGENT KIT
• Common Device Name: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• MDR Report Key: 12348564
• Report Number: 1415939-2021-00032
• Device Sequence Number: 11920566
• 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): 09/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 1L75-25
• Device Catalogue Number: 01L75-25
• Device Lot Number: 22007M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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 I2000SR INST, 03M74-02, ISR64055; ARC I2000SR INST, 03M74-02, ISR64055; ARC I2000SR INST, 03M74-02, (B)(4)