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

Catalog Number 07K62-25

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a negative bias while using architect tsh reagents.The following data was provided.The customer uses lab normal reference range: 0.3500 to 4.9400 uiu/ml.The customer stated the negative bias was approximately 0.4 to 0.6 uiu/ml for specimens in the normal range and an approximate 1.0 uiu/ml decrease for specimens in the 8.0 to 10.0 uiu/ml range.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of complaint trending data, a review of the historical performance, a review of the instrument log file, and a review of product labeling.Ticket searches determined normal complaint activity for the likely cause lot.A review of complaint trending data determined there are no adverse trends.World wide data was used to review the historical performance of reagent lot 91480ui00 and confirmed no systemic issues for this lot.A review of the instrument log file confirmed the results as per the complaint text.Labeling was reviewed and found to be adequate.No unusual variation was observed through a review of statistical analysis.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: ARCHITECT TSH
• Type of Device: TSH
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8199774
• MDR Text Key: 131928351
• Report Number: 3005094123-2018-00274
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Catalogue Number: 07K62-25
• Device Lot Number: 91480UI00
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER; LN 01L86-40 SN I1SR55747; LN 01L86-40, SN I1SR55747