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	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided 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 generated falsely decreased architect tsh results for 2 patients.The customer provided the following data (uiu/ml) which was questioned by the physician (customer provided reportable range 0.02 to 500): patient 1: (b)(6) 2016: initial 0.074, retest 1.527.Patient 2: (b)(6) 2016: initial 0.071, retest 3.711.There was no adverse impact to patient management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, in-house testing, a design history record review, a search for similar complaints, and a review of labeling.Return material was not available from the customer.An accuracy testing protocol was executed using a file sample from lot 66028ui00.The testing met acceptance criteria which determined the reagent is performing acceptably.A design history review did not find any non-conformances or deviations with the lot number in question.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency of the architect tsh reagent, ln 07k62, lot 66028ui00 was identified.
Additional Manufacturer Narrative
The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended.However, no systemic issue or product deficiency was identified.Correction: conclusion code.(b)(4).

• 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: 6171590
• Report Number: 3005094123-2016-00056
• Device Sequence Number: 716502
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2017

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: 12/15/2017
• Device Catalogue Number: 07K62-35
• Device Lot Number: 66028UI00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 12/22/2016; 06/15/2017
• 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: LN 03M74-02, SN (B)(4)