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	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased architect tsh results for a patient when using the architect i2000sr analyzer.The following data was provided by the customer during patient follow-up visits between (b)(6) to (b)(6) 2021: on (b)(6) 2021 sid (b)(6) = tsh (reagent lot 22171ui00 / architect (b)(4)) = 0.06 miu/l, ft3 = 3.40 ng/l, ft4 =7.1 ng/l on (b)(6) 2021 sid (b)(6) = tsh (reagent lot 23136ui00) = 0.08 miu /l (ran on alinity analyzer (b)(4)) on (b)(6) 2021 (no sample id provided) = tsh 0.05 miu /l, ft3 = 3.09 ng /l, ft4 = 7.3 ng /l on (b)(6) 2021 sid (b)(6) = tsh (reagent lot 26154ud00 / architect (b)(4)) = 0.06 miu /l, ft3 = 3.00 ng /l, ft4 = 8.7 ng /l.The patient was at (b)(6) for a routine check-up and generated a normal tsh result.The customer was asked to send their sample from (b)(6) 2021 to be retested on the roche cobas.The following results were tsh = 2.6 miu/l, ft3 = 3.55 ng/l, and ft4 = 0.9 ng/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed architect tsh results included a search for similar complaints, and the review of complaint text, trending data, labeling, field data review and device history records.Return testing was not completed as returns were not available.Trending review determined no trends were identified for the issue for the product.Device history record was reviewed and did not identify any non-conformances or deviations for the likely cause lots and complaint issue.The review of customer field data showed that the median population result for lots 26154ud00 and 22171ui00 are comparable with all other lots in the field.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect tsh lot numbers 26154ud00 and 22171ui00 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
• MDR Report Key: 12076888
• Report Number: 3005094123-2021-00120
• Device Sequence Number: 17000984
• 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): 09/10/2021

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: 08/17/2022
• Device Model Number: 7K62-30
• Device Catalogue Number: 07K62-30
• Device Lot Number: 26154UD00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 09/10/2021
• 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 I2SR REFURB-SEKAT, 03M74-97, (B)(6); ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6); ARC TSH RGT, 07K62-30, (B)(6); ARC TSH RGT, 07K62-30, (B)(6)