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

Model Number	7K62-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer due to privacy issues.
Event or Problem Description
The customer reported falsely depressed architect tsh results on one patient.The results provided were: on (b)(6) 2020, sid: (b)(6); initial = 0.0145miu/ml / retest = 2.5 / 2.5 result confirmed on same patient with a different tube.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation for a falsely depressed result included a search for similar complaints, a review of complaint text and the attached data, trending data, labelling, field data, and device history records.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review on lot 19505ui00 did not show any non-conformances, or deviations.Labelling was reviewed and found to adequately address the issue.Historical performance in the field of lot 19505ui00 using worldwide data through abbottlink was evaluated.The field data review showed that the median patient result is within established limits, indicating that the lot is performing as expected.Based on the investigation, no systemic issue or deficiency of the architect tsh reagent, lot 19505ui00 was identified.

• 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: 11036804
• Report Number: 3005094123-2020-00286
• Device Sequence Number: 1265905
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: 00380740014247
• Combination Product (Y/N): N
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (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): 02/22/2021

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: 02/10/2022
• Device Model Number: 7K62-30
• Device Catalogue Number: 07K62-30
• Device Lot Number: 19505UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/22/2021
• 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 I2000SR INST, 03M74-02, ISR50471; ARC I2000SR INST, 03M74-02, ISR50471