MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CYCLOSPORINE REAGENT KIT

Catalog Number 03R30-25

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 3r30, that has a similar us product distributed in the us, list 1l75.An evaluation was in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated false depressed architect cyclosporine of 16.4 ng/ml that was questioned.On (b)(6) 2021, the patient generated architect cyclosporine of 16.4 ng/ml, (b)(6) 2021 of 212.3 ng/ml, (b)(6) 2021 of 83.4 ng/ml.The account stated the timing of oral administration and blood collection remained the same although the value dropped on (b)(6) 2021.No specific patient information was available.No impact to patient management was reported.

Manufacturer Narrative

The lot search review did not identify an increase in complaint activity for the issue of falsely depressed results.A review of the tracking and trending did not identify an increase in complaint activity for the issue of falsely depressed results.No adverse trends were identified.A review in the corrective and preventive actions system did not identify any nonconformances or deviations associated with the likely cause lot number and complaint issue.A review of the labelling addresses the customer issue.Performance testing using an in house retained kit of lot 24472fn00 was performed.All acceptance criteria were met indicating the lot is performing acceptably.It is possible the depressed result is because of sample handling or instrumentation issues at the time of testing.The architect system operations manual, section 10, troubleshooting, provides probable causes and corrective actions for erratic results.No product deficiency was identified.

• Brand Name: ARCHITECT CYCLOSPORINE REAGENT KIT
• Type of Device: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12689464
• MDR Text Key: 278144119
• Report Number: 3008344661-2021-00192
• Device Sequence Number: 1
• Product Code: MKW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2021
• Device Catalogue Number: 03R30-25
• Device Lot Number: 24472FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR54776; ARC I2K PROC MOD, 03M74-01, ISR54776; ARC I2K PROC MOD, 03M74-01, ISR54776