MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TSH

Catalog Number	07K62-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
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.An evaluation is in process.
Event or Problem Description
The customer observed falsely depressed thyroid stimulating hormone (tsh) while using architect tsh reagents.The customer uses normal range 0.35 to 4.94 uiu/ml.The following data was provided for the same patient.Specimen 1 (drawn 3 hours after administration of thyradin); initial (sid (b)(6), tested (b)(6) 2018) 17.01 uiu/ml; repeat (sid (b)(6), tested (b)(6) "20018") 26.71 uiu/ml.Specimen 2 (drawn before administration of thyradin); initial (sid (b)(6), tested (b)(6) 2018) 26.42 uiu/ml; repeat (sid (b)(6), tested (b)(6) 2018) 22.15 uiu/ml.The customer stated the values from (b)(6) 2018 tests are correct.The patient was diagnosed with hashimoto disease (hypothyroidism) and was taking thyradin medication.No change to medication was reported.No impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, instrument log review, labeling review, and accuracy testing.The product was not returned.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Log review did not identify any issues that contributed to the customer issue.Labeling was reviewed and found to be adequate.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: ARCHITECT TSH
• Common Device Name: TSH
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 7847234
• Report Number: 3005094123-2018-00044
• Device Sequence Number: 19216475
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/29/2018

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: 05/23/2019
• Device Catalogue Number: 07K62-35
• Device Lot Number: 82312UI00
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/29/2018
• 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: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4).; LN 03M74-01 SN (B)(4).