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

Model Number	7K62-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely decreased architect tsh results on two patients.Results provided: (b)(6) 2021 sid (b)(6)= 0.04 uiu/ml (heparinized sample), different sample from (b)(6) 2021 under sid (b)(6)= 0.975 uiu/ml, new sample on (b)(6) 2021 sid (b)(6)= 0.99 uiu/ml; (b)(6) 2021 sid (b)(6)= 0.016 / 0.273 / 0.26 uiu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Patient identifier sids: (b)(6).
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause architect tsh reagent lot 29450ud00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.Inhouse testing determined that the accuracy performance is not negatively impacted.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances or deviations.A review of labeling concluded that the issue is sufficiently addressed.Based on our investigation no systemic issue or product deficiency of the architect tsh reagent lot 29450ud00 was identified.

• Brand Name: ARCHITECT TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12862324
• Report Number: 3005094123-2021-00225
• Device Sequence Number: 11914368
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: 00380740014247
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: 7K62-30
• Device Catalogue Number: 07K62-30
• Device Lot Number: 29450UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)
• Patient Sex: Unknown