MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I SIROLIMUS REAGENT KIT; SIROLIMUS TEST SYSTEM

Model Number	09P4120
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased alinity i sirolimus results on one patient specimen.The results provided were: on (b)(6) 2022.Sid (b)(6) =2.98 ng/l /repeated=8.05 ng/l /repeated few times=8.0, 8.1 and 8.7 ng/l which matched with patient¿s previous history.There was no reported impact to patient management.
Additional 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, accuracy testing of alinity i sirolimus reagent lot 30297fp00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of complaints determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.The ticket trending review of at least 12 months complaint data for the likely cause list number does not identify any adverse or non-statistical trend.Accuracy testing was performed with a retained kit of lot 30297fp00, and all specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.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 sirolimus reagent lot 30297fp00.

• Brand Name: ALINITY I SIROLIMUS REAGENT KIT
• Common Device Name: SIROLIMUS TEST SYSTEM
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14591872
• Report Number: 1415939-2022-00041
• Device Sequence Number: 5935457
• Product Code: NRP
• UDI-Device Identifier: 00380740150990
• UDI-Public: 00380740150990
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070822
• 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): 08/04/2022

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: 12/10/2022
• Device Model Number: 09P4120
• Device Catalogue Number: 09P41-20
• Device Lot Number: 30297FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown