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	11/07/2016
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.(b)(4): 1562 lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.
Event or Problem Description
The customer reports a falsely decreased architect tsh assay result on a new born infant sample generated on an architect (b)(4) analyzer.A result of 0.043miu/ml was generated on (b)(6) 2016 (b)(4).There was no sample left for retesting.On (b)(6) 2016, this infant had generated an architect tsh assay result of 3.17 miu/ml.On (b)(6) 2016, a new sample was taken from this patient and generated a lower than expected architect tsh assay result of 0.016 miu/l on architect (b)(4) analyzer serial number (b)(4).No suspect results were reported from the lab with no impact to patient management reported.
Additional Manufacturer Narrative
Accuracy testing was completed using an in-house retained kit of the architect tsh assay lot 66208ui00.No returns were made available from the customer site.The testing met acceptance criteria and therefore the lot performs as expected.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.No non statistical or adverse trends for this issue were noted.No further issues were identified.The architect tsh assay package insert contains information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.
Additional Manufacturer Narrative
The device evaluation was reassessed and concluded that a malfunction occurred; therefore, the device was not performing as intended and the evaluation codes were corrected.

• 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: 6144028
• Report Number: 3005094123-2016-00054
• Device Sequence Number: 16312001
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 04/15/2017

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: 12/30/2017
• Device Catalogue Number: 07K62-35
• Device Lot Number: 66208UI00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/04/2016
• Supplement Report FDA Received Date: 12/13/2016; 04/15/2017
• 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: ARCHITECT I2000SR ANALYZER LN:03M74-02; SN: (B)(4)
• Patient Age: 5 DA