MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number 07P4830

Device Problem Low Test Results (2458)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause alinity i tsh reagent lot 25007ud00 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 25007ud00 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-conformance's, potential non-conformance's and deviations related to the likely cause lot.This review did not identify any non-conformance's, potential non-conformance's or deviations.A review of labeling concluded that the issue is sufficiently addressed.No systemic issue or deficiency of the alinity i tsh lot 25007ud00 was identified.

Event Description

The customer reported a falsely decreased alinity i tsh result on a patient.Results provided: (b)(6) 2021 pt 1 = 0.312 / 1.8 iu/ml, another alinity = 1.7 iu/ml.Normal range - 0.4 - 3.5 iu/ml.No impact to patient management was provided.

• Brand Name: ALINITY I TSH REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12511897
• MDR Text Key: 272683105
• Report Number: 3005094123-2021-00180
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: 00380740131159
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2022
• Device Model Number: 07P4830
• Device Catalogue Number: 07P48-30
• Device Lot Number: 25007UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, (B)(4)