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

Model Number 7K62-25

Device Problem Low Test Results (2458)

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

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.

Event Description

The customer questioned falsely depressed architect tsh results on one patient.The following data was provided: initial result was 0.0102 uiu/ml; a new sample was drawn and generated a result of 2.0472 uiu/ml; (reference range 0.4 to 4.7 uiu/ml).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and inhouse testing of a retained kit of the complaint lot number.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues with the likely cause lot(s) and complaint issue.A review of labeling concluded that the issue is sufficiently addressed.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot 12200ui00.All specifications were met indicating that the lot is performing acceptably.Specimens run on the architect tsh assay must be processed according to the specimen test tube manufacturers¿ instructions.Insufficient processing, including deviations from recommended clotting times, centrifugation times, centrifugation speed and sample preparation techniques, may cause inaccurate results.Based on the investigation, no systemic issue or deficiency of the architect tsh lot number 12200ui00 was identified.

• Brand Name: ARCHITECT TSH
• Type of Device: TSH
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 10496872
• MDR Text Key: 206348522
• Report Number: 3005094123-2020-00200
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2021
• Device Model Number: 7K62-25
• Device Catalogue Number: 07K62-25
• Device Lot Number: 12200UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARCHITECT I2000SR ANALYZER, LIST 03M74-02,; SERIAL (B)(6)
• Patient Age: 65 YR