MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

A1 - patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 09p39 that has a similar product distributed in the us, list number 1l75.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely decreased alinity i cyclosporine results for 12 patient samples when using a particular reagent lot of the alinity i cyclosporine precipitation reagent kit.The customer stated that samples tested after opening a new bottle of precipitation / solubilization reagent were affected when measuring alinity i cyclosporine test.The following data was provided by the customer: all original sample results were tested on (b)(6) 2024, and the repeat testing was performed with a new bottle of precipitation reagent on (b)(6) 2024 (unit of measure used was ng/ml): (b)(6): initial result = 86; repeat result = 163 (b)(6): initial result = 87; repeat result = 166 (b)(6): initial result = 98; repeat result = 219 (b)(6): initial result = 95; repeat result = 207 (b)(6): initial result = 99; repeat result = 200 (b)(6): initial result = 92; repeat result = 155 (b)(6): initial result = 89; repeat result = 163 (b)(6): initial result = 81; repeat result = 152 (b)(6): initial result = 109; repeat result = 198 (b)(6): initial result = 148; repeat result = 307 (b)(6); initial result = 120; repeat result = 237 (b)(6): initial result = 126; repeat result = 222 there was no impact to patient management reported.

Event Description

The customer reported falsely decreased alinity i cyclosporine results for 12 patient samples when using a particular reagent lot of the alinity i cyclosporine precipitation reagent kit.The customer stated that samples tested after opening a new bottle of precipitation / solubilization reagent were affected when measuring alinity i cyclosporine test.The following data was provided by the customer: all original sample results were tested on (b)(6) 2024, and the repeat testing was performed with a new bottle of precipitation reagent on (b)(6) 2024 (unit of measure used was ng/ml): (b)(6) : initial result = 86; repeat result = 163 (b)(6) : initial result = 87; repeat result = 166 (b)(6) : initial result = 98; repeat result = 219 (b)(6) : initial result = 95; repeat result = 207 (b)(6) : initial result = 99; repeat result = 200 (b)(6) : initial result = 92; repeat result = 155 (b)(6) : initial result = 89; repeat result = 163 (b)(6) : initial result = 81; repeat result = 152 (b)(6) : initial result = 109; repeat result = 198 (b)(6) : initial result = 148; repeat result = 307 (b)(6) ; initial result = 120; repeat result = 237 (b)(6) : initial result = 126; repeat result = 222.There was no impact to patient management reported.

Manufacturer Narrative

Updated d10 - concomitant product to include: alnty i processing modu,03r65-01, (b)(6).The complaint investigation for falsely depressed alinity i cyclosporine results when using alinity i cyclosporine whole blood precipitation reagent kit included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed 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.The ticket search by lot number indicates the product lot was performing as expected.A review of ticket tracking and trending did not identify any trends regarding commonalities for lot number and issue.The device history record was reviewed and did not identify any non-conformances, potential non-conformances, or deviations associated with the list number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for alinity i cyclosporine reagent lot 54150fn00 and alinity i cyclosporine whole blood precipitation regent lot number 311127.

• Brand Name: ALINITY I CYCLOSPORINE REAGENT KIT
• Type of Device: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18915140
• MDR Text Key: 337859512
• Report Number: 3008344661-2024-00037
• Device Sequence Number: 1
• Product Code: MKW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 09P39-20
• Device Lot Number: 54150FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I CYCLO PRECIP, 09P39-40, (B)(6) ; ALINITY I CYCLO PRECIP, 09P39-40, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)