Catalog Number 02K46-20 |
Device Problem
High Test Results (2457)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
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 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.
|
|
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.
|
|
Search Alerts/Recalls
|