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

Model Number	7K62-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely depressed tsh result on the architect i1000sr analyzer.The following data was provided: initial 0.04 uiu/ml, repeats between 0.02 and 0.06.The sample was found in the normal range on another method at another facility: 2.8, 2.2, 2.79.The patient has been diagnosed with kidney cancer in 2016.The patient has been taking the following medications, continuously around 3 years: omnic ocas 0.4 mg and for around 5 years: pressat 10 mg, micardis hct 80/25 mg, selozok 50 mg.An ultrasound on the thyroid was normal.There was no negative impact to patient management.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.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' complaint investigation no product deficiency was identified.

• 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: 7359096
• Report Number: 3005094123-2018-00007
• Device Sequence Number: 1710810
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: (01)00380740105969(17)180809(10)73291UI00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: 08/09/2018
• Device Model Number: 7K62-35
• Device Catalogue Number: 07K62-35
• Device Lot Number: 73291UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1