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 05/08/2020

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.

Event Description

The customer observed falsely decreased alinity i tsh results for one patient.The following data was provided (customer¿s reference range is 0.30-4.2 mu/l): initial result, on (b)(6) 2020, was 0.030 mu/l.The sample was tested at another hospital on a siemens analyzer and the result, on (b)(6) 2020, was 1.4 mu/l.The patient¿s historical laboratory results were provided (b)(6).The patient was also tested using a siemen¿s tsh assay on (b)(6) 2020 and the result was 0.75 mu/l, which is in the normal range.It was noted that the customer suspects interference with the alinity i tsh assay.It was noted that the patient was prescribed thiamazol on (b)(6) 2019 and diagnosed with subclinical hyperthyroidism based on graves¿ disease using the patient¿s low tsh results and slightly increased anti-tsh r result, as well as the patient¿s clinical picture and symptoms.The treatment was stopped in (b)(6) 2021 because the patient was tested at another hospital using a siemen¿s assay and the tsh results were in the normal range.There was no additional impact to patient management reported.

Manufacturer Narrative

Additional patient data was provided by the customer and added to field b5 - describe event or problem and an additional concomitant product was added.

Event Description

The customer observed falsely decreased alinity i tsh results for one patient.The following data was provided (customer¿s reference range is 0.30-4.2 mu/l): initial result, on (b)(6) 2020, was 0.030 mu/l.The sample was tested at another hospital on a siemens analyzer and the result, on (b)(6) 2020, was 1.4 mu/l.The patient¿s historical laboratory results were provided (customer¿s reference range for free t4 is 9-19 pmol/l; for free t3 is 2.9-4.9 pmol/l; for anti-tsh r is <3.4 iu/l): (b)(6) 2019 tsh was 0.016 mu/l; free t4 was 10 pmol/l.(b)(6) 2019 tsh was 0.053 mu/l; free t4 was 10 pmol/l.(b)(6) 2019 anti-tsh r was 4.2 iu/l.(b)(6) 2019 tsh was 0.022 mu/l; free t4 was 11 pmol/l.(b)(6) 2019 tsh was 0.022 mu/l; free t4 was 11 pmol/l; free t3 was 4.9 pmol/l.(b)(6) 2019 tsh was 0.021 mu/l; free t4 was 10 pmol/l; free t3 was 4.7 pmol/l.(b)(6) 2019 tsh was 0.025 mu/l; free t4 was 10 pmol/l; free t3 was 4.5 pmol/l.(b)(6) 2020 tsh was 0.039 mu/l; free t4 was 9 pmol/l; free t3 was 3.7 pmol/l.(b)(6) 2020 free t4 was 9 pmol/l; free t3 was 4.9 pmol/l.(b)(6) 2021 tsh was 0.028 mu/l; free t4 was 10 pmol/l; anti-tsh r was 1.6 iu/l.(b)(6) 2021 tsh was 0.0212 mu/l, 1:1 dilution with saline was 0.0452, 1:5 dilution was 0.189 mu/l.(b)(6) 2021 tsh was 0.0228 mu/l, 1:1 dilution with alinity i diluent was 0.0443, 1:5 dilution was 0.2614 mu/l.(b)(6) 2021 tsh was <0.020 mu/l; free t4 was 12 pmol/l.The patient was also tested using a siemen¿s tsh assay on (b)(6) 2020 and the result was 0.75 mu/l, which is in the normal range.It was noted that the customer suspects interference with the alinity i tsh assay.It was noted that the patient was prescribed thiamazol on (b)(6) 2019 and diagnosed with subclinical hyperthyroidism based on graves¿ disease using the patient¿s low tsh results and slightly increased anti-tsh r result, as well as the patient¿s clinical picture and symptoms.The treatment was stopped in (b)(6) 2021 because the patient was tested at another hospital using a siemen¿s assay and the tsh results were in the normal range.There was no additional impact to patient management reported.The following patient results were provided by the customer on (b)(6) 2021: sample id (b)(6) tsh, on (b)(6) 2021, was 0.061, repeated on the siemens assay was 2.2 mu/l.The sample was sent to amsterdam university hospital and the result was 2.28 me/l, which is in their normal range.There was no additional impact to patient management reported.

Manufacturer Narrative

Upon further review, section d4 - lot number was updated from unknown to 26158ud00, d4 - expiration date was updated to 09/01/2022, concomitant product alnty i processing modu,03r65-01,(b)(6) was added.

Manufacturer Narrative

The complaint investigation for falsely decreased alinity i tsh results included a search for similar complaints, the review of complaint text, trending data, labeling, device history records, in-house testing, and return sample testing.Trending review determined no related trend for the issue for the product.Device history record review on lot 26158ud00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Return testing was performed on the returned patient sample ((b)(6) sample 1 and 2), using reagent lot 26158ud00, the hbt result was 0.002 iu/ml, which is outside the customer¿s reference range, therefore the customer observation was reproduced.Accuracy testing was performed using panels, which mimics patient samples, and an in-house retained kit of lot 26158ud00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency with the alinity i tsh reagent lot number 26158ud00 was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 12302237
• MDR Text Key: 265861082
• Report Number: 3005094123-2021-00146
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: 00380740131159
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K983442
• 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,Followup,Followup
• Report Date: 01/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 07P4830
• Device Catalogue Number: 07P48-30
• Device Lot Number: 26158UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 08/03/2021; 09/14/2021; 01/17/2022
• Supplement Dates FDA Received: 08/27/2021; 10/04/2021; 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, AI01257