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

Model Number 07P4820

Device Problem Low Test Results (2458)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up will be provided when the investigation is complete.Patient identifier: complete entry = (b)(6).Section a patient information: no further information was provided.

Event Description

The customer obtained a falsely depressed alinity i tsh result for a patient with no history of treatment.On (b)(6) 2021 sample id (b)(6) generated a result of 0.09 miu/l.On (b)(6) 2021 the sample was retested and generated a normal result of 1.10 miu/ml.A new sample generated tsh result of 0.84 miu/l for tsh and 22.6 for t4.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.The customer provided additional falsely depressed patient results.Section b5 was updated to include three additional falsely depressed results.Section a1 multiple should also include (b)(6), (b)(6) and (b)(6).

Event Description

The customer provided additional falsely depressed alinity i tsh results.(b)(6) 2021 sample id (b)(6): 0.19 miu/l; second sample 2.01 miu/l; (b)(6) 2021 sample id (b)(6): 0.03 miu/l; second sample 3.14 miu/l; (b)(6) 2021 sample id (b)(6): 0.06 miu/l; retest 1.4 miu/l.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.The customer provided additional falsely depressed patient results.Section b5 was updated to include two additional falsely depressed results and a1 was changed to multiple.Multiple = 021138563202, 021148622501 and 12109866602.

Event Description

The customer provided additional falsely depressed alinity i tsh results.(b)(6) 2021 sample id (b)(6): 0.16 miu/l; second sample (b)(6): 0.61 miu/l.(b)(6) 2021 sample id (b)(6): 0.043 miu/l; retest on architect 4.38 miu/l; alinity 3.91 miu/l.

Manufacturer Narrative

The investigation included review of the information provided by the customer, complaint data, trending data, labeling and device history records.In-house testing of the complaint lots was also completed.Return testing was not completed as returns were not available.Review of complaint trending reports for the alinity i tsh assay did not identify any trends for the complaint issue.Device history records for the complaint lots were reviewed and did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Accuracy testing was completed using panels which mimic patient samples and an in-house retained kit of lot 28117ud00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Based on this investigation, no systemic issue or deficiency of the alinity i tsh assay was identified.The incorrect expiration date was previously provided.D4 expiration date was changed from 06-oct-2021 to 06-oct-2022.

• 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
• MDR Report Key: 12348528
• MDR Text Key: 267478201
• Report Number: 3005094123-2021-00155
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131142
• UDI-Public: 00380740131142
• Combination Product (y/n): N
• PMA/PMN Number: K983442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: 07P4820
• Device Catalogue Number: 07P48-20
• Device Lot Number: 28117UD00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(4).; ALNTY I PROCESSING MODU, 03R65-01, (B)(4).; ALNTY I PROCESSING MODU, 03R65-01, (B)(4).; ALNTY I PROCESSING MODU, 03R65-01,(B)(4).; ALNTY I PROCESSING MODU, 03R65-01, AI01588