MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	7K62-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: patient 1 and patient 2.Section a2 - age at time of event: patient 1 is 76 years old, patient 2 is above 65 years old.Section a3 - gender: both patient 1 and patient 2 are male.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely decreased architect tsh results on two male patients with osteopenia.Due to persistently low tsh and potential comorbidities, methimazole treatment was initiated.Both patients had normal thyroid uptake and normal i-123 scan (with no iv contrast).The customer stated there was no harm to the patients due to taking methimazole or from the i-123 scan.The following data was provided: customer¿s normal range for tsh: 0.35 iu/ml to 5.0 iu/ml patient 1 (76-year-old male): (b)(6) 2023 architect tsh result = 0.12 iu/ml (low), architect free t4 = normal quest tsh result = 4.98 iu/ml (high) (b)(6) 2023 architect tsh result = 1.49 iu/ml (normal), architect free t4 = 0.4 (low) the patient was intermittently on methimazole from january 2020 through may 2023 with dosage ranging anywhere from 5 to 20 mg daily.Patient 2 (above 65 years of age, male) with a history coronary artery disease.The patient had low architect tsh results for years.On (b)(6), 2023, the patient had a normal tsh and normal ft4 result.However, prohealth and quest tsh results were high.This patient has been atypical clinically and was not symptomatic at that time.(b)(6) architect tsh result = normal, architect free t4 = normal.(b)(6) 2023 prohealth tsh result = 25 (high).(b)(6) 2023 quest tsh result = 31 (high).The patient was intermittently on methimazole since march 2022 with dosage ranging anywhere from 5 to 15 mg daily.No additional impact to patient management was reported.
Event or Problem Description
On (b)(6)2023, the customer provided additional information on patient 2.The patient returned on (b)(6)2023 and tsh testing was performed.The following data was provided: patient 2 06jul2023 architect tsh results (undiluted) = 0.10, 0.09, 0.09, 0.10, 0.10 ¿iu/ml architect tsh results (1:5 dilution) = 0.43, 0.41, 0.43, 0.43, 0.43 ¿iu/ml newington (alternate site) tsh result = 0.09 ¿iu/ml.
Additional Manufacturer Narrative
Section b5 - describe event or problem: additional information received on (b)(6)2023 and is documented in section b5.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased architect tsh results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.Return sample testing was also completed using an in-house retained reagent kit.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates the reagent lot is performing as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with the lot number 43034ud00 and complaint issue.The overall performance of the architect tsh reagent was reviewed using field data from customers worldwide.The median population result for lot 43034ud00 is within established limits, indicating that the lot is performing acceptably in the field.A review of labeling was performed and found to sufficiently address the customer¿s issue.An in-house testing was performed for a patient sample returned by the customer.All validity and acceptance criteria were met which demonstrates that the lot is performing acceptably.Additionally, there was no interference observed within the sample.Based on our investigation, no systemic issue or deficiency was identified with the architect tsh reagent, lot number 43034ud00.The following sections have been corrected to reflect the current contact (b)(6): g1-contact office first name g1-contact office last name g1-contact office address 1 g1-contact office city g1-contact office postal code g1-contact office country g1-contact office phone number g1-contact office email g1-contact office fax number.
Event or Problem Description
The customer reported falsely decreased architect tsh results on two male patients with osteopenia.Due to persistently low tsh and potential comorbidities, methimazole treatment was initiated.Both patients had normal thyroid uptake and normal i-123 scan (with no iv contrast).The customer stated there was no harm to the patients due to taking methimazole or from the i-123 scan.The following data was provided: customer¿s normal range for tsh: 0.35 iu/ml to 5.0 iu/ml patient 1 (76-year-old male): (b)(6) 2023 architect tsh result = 0.12 iu/ml (low), architect free t4 = normal quest tsh result = 4.98 iu/ml (high) (b)(6) 2023 architect tsh result = 1.49 iu/ml (normal), architect free t4 = 0.4 (low) the patient was intermittently on methimazole from january 2020 through may 2023 with dosage ranging anywhere from 5 to 20 mg daily.Patient 2 (above 65 years of age, male) with a history coronary artery disease.The patient had low architect tsh results for years.On (b)(6) 2023, the patient had a normal tsh and normal ft4 result.However, prohealth and quest tsh results were high.This patient has been atypical clinically and was not symptomatic at that time.(b)(6) 2023 and (b)(6) 2023, architect tsh result = normal, architect free t4 = normal (b)(6) 2023 prohealth tsh result = 25 (high) (b)(6)2023 quest tsh result = 31 (high) the patient was intermittently on methimazole since march 2022 with dosage ranging anywhere from 5 to 15 mg daily.No additional impact to patient management was reported.On (b)(6) 2023, the customer provided additional information on patient 2.The patient returned on (b)(6)2023 and tsh testing was performed.The following data was provided: patient 2 (b)(6) 2023 architect tsh results (undiluted) = 0.10, 0.09, 0.09, 0.10, 0.10 ¿iu/ml architect tsh results (1:5 dilution) = 0.43, 0.41, 0.43, 0.43, 0.43 ¿iu/ml newington (alternate site) tsh result = 0.09 iu/ml.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17244183
• Report Number: 3005094123-2023-00165
• Device Sequence Number: 6831263
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/01/2024

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: 01/20/2024
• Device Model Number: 7K62-35
• Device Catalogue Number: 07K62-35
• Device Lot Number: 43034UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 12/22/2023
• Initial Report FDA Received Date: 07/01/2023
• Supplement Report FDA Received Date: 07/19/2023; 01/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 76 YR
• Patient Sex: Male