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	Insufficient Information (4580)
Date of Event	12/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer observed falsely depressed architect tsh results for multiple pediatric samples.The following example data was provided (normal range - 0.35 iu/ml to 4.94 iu/ml): (b)(6) 2022 sample id (b)(6) initial result = 0.57 uiu/ml, repeat result in 1:10 dilution = 0.659 uiu/ml.(b)(6) 2022 sample id (b)(6) initial result = 0.11 uiu/ml, repeat = 1.34 uiu/ml, repeat result in 1:15 dilution = 1.62 uiu/ml.(b)(6) 2022 sample id (b)(6) initial result = 1.51 uiu/ml, repeat result in 1:5 dilution = 2.14 uiu/ml (b)(6) 2022 sample id (b)(6) initial result = 0.04 uiu/ml, repeat result at a different laboratory = 2.0 uiu/ml.(b)(6) 2022 sample id (b)(6) initial result = 0.7 uiu/ml, repeat = 3.07 uiu/ml, repeat result in 1:6 dilution = 2.4534 uiu/ml.The customer further indicated the precision issue associated with the pediatric samples have the potential for far-reaching consequences, e.G.Unnecessary control visits for newborns in the hospital, up to actually unnecessary drug treatment.To date it is unknown if there was any unnecessary treatment given or any adverse impact to any patients.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for patient identification: sids (b)(6).All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Additional information received after submitting initial.See sections: b1 - adverse event/product problem , b2 - outcomes attributed to ae, d4 - expiration date , d10 - concomitant product- additional instrument added, h1 - type of reportable event, h4 - device mfg date.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed architect tsh results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, cross functional team review, and retained product analysis.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any trends for the complaint lot, and indicates the lot is performing as expected.Device history record review did not identify any issues associated with the customer¿s observation.Accuracy testing of the retained reagent lot met acceptance and validity criteria.Labeling was reviewed and found to adequately address the issue under review.The cross functional team review concluded the customer did not follow product labeling as required; therefore, this event was deemed incorrect use.Based on the investigation, no systemic issue or deficiency with the architect tsh reagent lot 43041ud00 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16035636
• Report Number: 3005094123-2022-00302
• Device Sequence Number: 7224860
• 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,Followup
• Report Date (Section B): 03/17/2023

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: 01/26/2024
• Device Model Number: 7K62-30
• Device Catalogue Number: 07K62-30
• Device Lot Number: 43041UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 03/09/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/05/2023; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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, ISR50934; ARC I2000SR INST, 03M74-02, ISR50934; ARC I2000SR INST, 03M74-02, ISR50934; ARC I2000SR INST,03M74-02,ISR50920; ARC TSH RGT, 07K62-30, 44389UD00; ARC TSH RGT, 07K62-30, 44389UD00; ARC TSH RGT, 07K62-30, 44389UD00
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown