MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number 7K62-25

Device Problem Low Test Results (2458)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6).All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely depressed architect tsh results on one patient.On (b)(6) 2020, the initial tsh result for sid (b)(6) was 0.0972 ulu/ml, rerun after the sample was recentrifuged was 0.8972 ulu/ml (normal range 0.35 ulu/ml to 4.94 ulu/ml).The sample was repeated on the siemens analyzer and the result was 0.90 uiu/ml.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation included a search for similar complaints, and the review of complaint text, trending data, labelling, field data review and device history records.Return testing was not completed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with the complaint lot.Historical performance was evaluated using worldwide field data and the patient median result for lot 16301ui00 was found to be within established limits, indicating that the lot performs as expected.Based on the investigation, no systemic issue or deficiency of the architect tsh lot number 16301ui00 was identified.

• Brand Name: ARCHITECT TSH REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11087342
• MDR Text Key: 241230956
• Report Number: 3005094123-2020-00293
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 00380740014230
• UDI-Public: 00380740014230
• Combination Product (y/n): N
• PMA/PMN Number: K983442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2021
• Device Model Number: 7K62-25
• Device Catalogue Number: 07K62-25
• Device Lot Number: 16301UI00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR61556; ARC I1000SR MOD, 01L86-01, I1SR61556