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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint trending report review determined that there is no non statistical or adverse trend for the product for the complaint issue.However, as the reagent is unknown, no lot review, performance testing or batch record review could be performed.Statistical process control (spc) charts for architect tsh reagents for low, medium and high control and panel n (normal) testing of architect tsh reagent lots show that this assay is performing within the low, medium and high control and panel limits.A review of the performance of this assay on market was completed.The review shows that the tsh product overall is performing acceptably.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 evidence to reasonably suggest a product malfunction occurred.The device failed to meet performance specifications or otherwise perform as intended at the customer site.However, no systemic issue or product deficiency was identified.Lot/serial number was not provided by the customer; therefore, only a partial udi is known.
Event or Problem Description
The customer reports that one patient who has been tested on the architect platform for the past three years has typically generated low architect tsh assay results of less than 0.1 miu/ml (normal reference range of 0.35 - 4.94 uiu/ml) with free t3 and free t4 results within normal reference ranges.A current sample was tested at another laboratory on a non-abbott platform with results for all three assays within their normal reference ranges (no specific values provided).The patient has no known disease issues.There is no impact to patient management reported.

• 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: 6567782
• Report Number: 3005094123-2017-00023
• Device Sequence Number: 926633
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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 Catalogue Number: 07K62-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 05/15/2017
• 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: 03M74-01; SN: (B)(4)