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

Model Number	7K62-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account stated false depressed architect tsh results were generated on a patient sample that tested higher on non-abbott methods.Using the same patient sample collected on (b)(6) 2021, testing generated architect tsh of 0.3837, 0.3829 uiu/ml, but non-abbott method of >5, 4.8, 4.5 uiu/ml.The sample was sent to a different laboratory with alinity tsh of 0.38 uiu/ml.A new sample collected on (b)(6) 2021, generated architect tsh of 0.4993, 0.4807 uiu/ml but non-abbott method 5.08 uiu/ml and another lab alinity tsh of 0.38 uiu/ml.The patient is under thyroid treatment until recently with low tsh values and receiving statin treatment and folic acid supplementation.The physicians were expecting a tsh value increase.The endocrinologist cannot decide which results are correct for the patient.The account uses a tsh normal range of 0.35 iu/ml to 4.94 iu/ml.Testing with the alinity method was performed for troubleshooting and comparative testing only.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint evaluation included a search for similar complaints, and the review of complaint text, trending data, labelling, device history records and testing of a retained sample of the complaint lot.Return testing was not completed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review determined no adverse trend for the issue for the product.Device history record review on lot 21222ui00 did not show any non-conformances, or deviations.Labelling was reviewed and found to adequately address the issue under review.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot 21222ui00.All specifications were met indicating that the lot is performing acceptably.No product deficiency was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• Brand Name: ARCHITECT TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11532678
• Report Number: 3005094123-2021-00046
• Device Sequence Number: 17277291
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K983442
• 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): 05/18/2021

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: 04/05/2022
• Device Model Number: 7K62-35
• Device Catalogue Number: 07K62-35
• Device Lot Number: 21222UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2K PROC MOD, 03M74-01, ISR03745; ARC I2K PROC MOD, 03M74-01, ISR03745
• Patient Age: 66 YR