MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ARCHITECT TSH

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	08/05/2020
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.All available patient information is included.Additional patient details are not available.
Event or Problem Description
The customer reported decreased architect thyroid stimulating hormone (tsh) assay results for an (b)(6) female patient.The customer provided sid (b)(6): initial = 0.085 miu/l, repeat = 0.247 miu/l (0.5 to 3.0 miu/l).There was no impact to patient management reported.
Additional Manufacturer Narrative
The evaluation of the customer¿s issue included a search for similar complaints, and review of the complaint text, trending data, labeling, and device history records.Trending review determined no trend for the issue for the product.Device history record review on lot 12236ui00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Return testing was not completed as returns were not available.In house testing of panels, which mimic patient samples, was completed using retained samples of the complaint lot 12236ui00.All specifications were met indicating that the lot is performing acceptably.Based on all available information no product deficiency was identified.

• Brand Name: ARCHITECT TSH
• Common Device Name: TSH
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford N3900 ; EI N3900
• MDR Report Key: 10449880
• Report Number: 3005094123-2020-00184
• Device Sequence Number: 19746905
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: 00380740014247
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/15/2020

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: 07/22/2021
• Device Model Number: 7K62-30
• Device Catalogue Number: 07K62-30
• Device Lot Number: 12236UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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, SN (B)(4); ARCHITECT I2000SR ANALYZER; LN 03M74-02, SN (B)(4)
• Patient Age: 81 YR