MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TSH

Catalog Number	07K62-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in-process.
Event or Problem Description
The customer generated a falsely decreased architect tsh result.The customer provided the following results: (b)(6) 2018: sid (b)(6), architect tsh result: 1.907 miu/l, retested using another architect analyzer: 1.9 miu/l the specimen was tested using the siemens, beckman and roche methods as follows: siemens: 4.689 miu/l, roche 5.11 miu/l and beckman 5.731 and 5.690 the customer indicated the architect results align with the patient clinical state per the customer.On (b)(6) 2018 a new specimen was dran from the patient and generated the following results: architect tsh result: 3.618 miu/l.The specimen was tested using the beckman method: 9.783 miu/l.There was no adverse impact to patient management reported.
Additional Manufacturer Narrative
Lot number originally documented in incorrect field on initial manufacture report.Further investigation of the customer issue included a review of the complaint text, testing of the return specimen, in-house testing, field data review, a design history record review, a search for similar complaints, and a review of labeling.Return material was provided by the customer.The returned patient sample was tested with the likely cause lot.The sample was tested for dilution linearity using a manual 1:10 dilution and then further treated with a heterophilic blocking tube (hbt).The neat sample gave similar results to that observed by the customer and therefore the customer observation was reproduced.The results for the sample dilution were outside the evaluation acceptance criteria.The hbt treatment result did not exceed the allowable difference therefore indicating that there is nonspecific binding from an unidentified interferent in the sample received that was not eliminated during hbt treatment.Accuracy testing was performed using an in-house retain kit and all specifications were met indicating the lot is preforming acceptably.An analysis utilizing customer field data was used to assess the specificity of the assay.Instrument data analytics (ida) reports for the architect tsh assay were reviewed to determine if the median patient values have shifted over time.The analysis concluded that all reagent lots read patient results.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect tsh reagent, ln 07k62, lot 87045ui00, was identified.

• Brand Name: ARCHITECT TSH
• Common Device Name: TSH
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 7911343
• Report Number: 3005094123-2018-00059
• Device Sequence Number: 11330185
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 09/09/2019
• Device Catalogue Number: 07K62-35
• Device Lot Number: 87045UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN (B)(4), SN (B)(4); LN (B)(4), SN (B)(4)
• Patient Age: 79 YR