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

Model Number	7K62-35
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Age at time of event the customer stated the patient was a newborn baby, however no specific birth date or age were provided.
Event or Problem Description
The customer observed falsely depressed thyroid stimulating hormone (tsh) results while using the architect tsh reagents.The following data was provided for the same patient.Specimen 1 ((b)(6)) initial less than 0.1, repeat 0.004, 6.22.Specimen 2 (no sid provided) initial 4.27, not repeated.The patient is a newborn baby that was diagnosed with metabolic and endocrine disorders.No impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, instrument log review, labeling review, and accuracy testing.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.Log review did not identify any issues that contributed to the customer issue.The product was not available for return.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: 7038778
• Report Number: 3005094123-2017-00069
• Device Sequence Number: 939537
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: (01)00380740105969(17)180809(10)73291UI00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/08/2018

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
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1