MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.See mfr# 3005094123-2023-00086-00 for the other lot# submission.
Event or Problem Description
The customer reported a falsely decreased architect tsh result on a preterm newborn patient.Results provided: (b)(6) 2023 sid: (b)(6) on lot# (47474ud00) = 7.016, 1:10 dilution = 14.5 uiu/ml, cobas = 18.62 (no uom provided).New sample, same patient (b)(6) 2023 sid: (b)(6) (lot# 48544ud00) = 4.58, 1:10 dilution = 15.092 / 11.934 uiu/ml, cobas = 18.2 (no uom provided).The neonatal preterm infant with down syndrome had a delay in thyroid treatment.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause architect tsh reagent lot 47474ud00 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 of reagent lot 47474ud00 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 47474ud00 was identified.See mfr# 3005094123-2023-00086-00 for the other lot# submission.
Event or Problem Description
The customer reported a falsely decreased architect tsh result on a preterm newborn patient.Results provided: 08mar2023 sid (b)(6) on lot# (47474ud00) = 7.016, 1:10 dilution = 14.5 uiu/ml, cobas = 18.62 (no uom provided).New sample, same patient 13mar2023 sid (b)(6) (lot# 48544ud00) = 4.58, 1:10 dilution = 15.092 / 11.934 uiu/ml, cobas = 18.2 (no uom provided).The neonatal preterm infant with down syndrome had a delay in thyroid treatment.

• Brand Name: ARCHITECT TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17084244
• Report Number: 3005094123-2023-00089
• Device Sequence Number: 2834235
• Product Code: JLW
• UDI-Device Identifier: 00380740014247
• UDI-Public: 00380740014247
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2024
• Device Model Number: 7K62-30
• Device Catalogue Number: 07K62-30
• Device Lot Number: 47474UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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, ISR50611; ARC I2000SR INST, 03M74-02, ISR50611
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown