MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I CYCLOSPORINE REAGENT KIT

Catalog Number 09P39-20

Device Problem Low Test Results (2458)

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

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely decreased alinity i cyclosporine results on one patient.The results provided were: (b)(6) 2022.Sid (b)(6) =63.4 ng/ml /repeated=112.4 ng/ml /after calibration=66.5 ng/ml and 170.0 ng/ml the customer process same specimen with new lot number of reagent 32283fn00 on (b)(6) 2022 initial=95.8 ng/ml /repeated=159.4 ng/ml there was no reported impact to patient management.

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 of alinity i cyclosporine reagent lot 32283fn00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of 12 months of complaint data did not identify any adverse trends or any non-statistical trends or any atypical complaint activity associated with this described issue.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Per product labeling, the steps for the manual pretreatment procedure must be completed precisely and in immediate succession.Results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.If the cyclosporine results are inconsistent with clinical evidence, additional testing is recommended.Individual cyclosporine values cannot be used as the sole indicator for making changes in treatment regimen and each patient should be thoroughly evaluated clinically before changes in treatment regimens are made.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 alinity i cyclosporine reagent lot 32283fn00.

• Brand Name: ALINITY I 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14636693
• MDR Text Key: 298574539
• Report Number: 3008344661-2022-00062
• Device Sequence Number: 1
• Product Code: MKW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Catalogue Number: 09P39-20
• Device Lot Number: 32283FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)