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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.
Event or Problem Description
The customer observed a falsely depressed tsh result on the architect i2000sr analyzer.The following data was provided for a female patient (b)(6) with previous surgical thyroid removal and currently taking eutirox and etatsizin: (b)(6), repeat 2.3946 miu/l.Initial tsh result were in normal range.Repeats 23.5 miu/l, 31.8 uiu/ml (on other methods).A new sample initial 2.12, repeated dilutions 15.53, 21.17, 23.64, 24.6, 36.84 miu/l there was no impact to patient management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency 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: 6858523
• Report Number: 3005094123-2017-00055
• Device Sequence Number: 11048258
• Product Code: JLW
• UDI-Device Identifier: 00380740105969
• UDI-Public: 00380740105969
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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: 10/06/2018
• Device Catalogue Number: 07K62-35
• Device Lot Number: 75300UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1