MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ALINITY I TSH REAGENT KIT

Model Number 07P4830

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Patient identifier complete sid: (b)(6).

Event Description

The customer reported discrepant alinity i tsh results on a cord blood sample of a patient.Results provided: (b)(6) 2020 sid (b)(6) = 0.599 / 4.5255 uiu/ml, architect = 2.1427 miu/ml (result reported).Cord blood tsh lab reference range: 1 - 20 ulu/ml.No impact to patient management was reported.

Event Description

The customer reported discrepant alinity i tsh results on a cord blood sample of a patient.Results provided: 08aug2020 sid (b)(6)= 0.599 / 4.5255 uiu/ml, architect = 2.1427 miu/ml (result reported).Cord blood tsh lab reference range: 1 - 20 ulu/ml.No impact to patient management was reported.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause alinity i tsh reagent lot 11104ui00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.A retained kit of reagent lot 11104ui00 was tested for accuracy and the data shows that the performance of the lot is performing acceptably.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances or deviations.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: ALINITY I TSH REAGENT KIT
• Type of Device: TSH
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 10479860
• MDR Text Key: 244153004
• Report Number: 3005094123-2020-00194
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: 00380740131159
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2021
• Device Model Number: 07P4830
• Device Catalogue Number: 07P48-30
• Device Lot Number: 11104UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE LIST 03R65-01; ALNTY I PROCESSING MODU, 03R65-01, (B)(4); SERIAL (B)(6)