MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT ANTI-TG REAGENT

Catalog Number	02K46-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.All available patient information was included.Additional patient details are not available.Refer to manufacturer report number 1415939-2019-00193 for anti-tpo submission.
Event or Problem Description
The customer reported a falsely increased architect anti-tg and anti-tpo results on one patient diagnosed with hashimoto's thyroiditis.Results provided: anti-tpo = 263.3 iu/ml (ref range: <5.61 iu/ml); anti-tg = 622.1 iu/ml (reference range: <4.11 iu/ml).Additional testing provided: tsh = 2.192 miu/ml (reference range: 0.35-4.94 miu/ml); t4 = 76.8 nmol/l (reference range: 62.68-150.84 nmol/l); ft4 = 10.1 pmol/l (reference range: 9.01-19.05 pmol/l); t3 = 1.32 nmol/l (reference range: 0.89-2.44 nmol/l); ft3 = 3.95 pmol/l (reference range: 2.63-5.70 pmol/l).There was no information as to the impact of patient health reported.Customer reported incorrect treatment was provided for the last six months from initial testing.Requested further clarification from customer regarding this issue.To be conservative, will make ticket an adverse event pending further information from the customer.
Additional Manufacturer Narrative
The account provided additional information which makes the previously reported issue non-reportable.On the initial report there was no information provided as to the impact to patient health.Additional information was received from the account verifying there was no impact to patient health and therefore no evidence an adverse event occurred.This additional information renders the decision of this complaint not an adverse event and not reportable.No further follow-up will be provided.

• Brand Name: ARCHITECT ANTI-TG REAGENT
• Common Device Name: ANTI-TG
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9100662
• Report Number: 1415939-2019-00194
• Device Sequence Number: 2030570
• Product Code: JZO
• UDI-Device Identifier: 00380740003432
• UDI-Public: 00380740003432
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/02/2019

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 Catalogue Number: 02K46-20
• Device Lot Number: 55647UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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 LIST 03M74-02; ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(4); SERIAL (B)(4)
• Outcome Attributed to Adverse Event: Other