A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
|
Back to Search Results |
|
Model Number 7K78-25 |
Device Problem
False Positive Result (1227)
|
Patient Problem
Misdiagnosis (2159)
|
Event Date 11/20/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
An evaluation is in process.A final report will be submitted when the evaluation is complete.Patient identifier.Sids: (b)(6).All available patient information was included.Additional patient details are not available.
|
|
Event Description
|
The customer reported a false positive architect total b-hcg on a (b)(6) yr old female patient.Results provided: (b)(6) 2020 sid (b)(6) = 1318.89 iu/l, (b)(6) 2020 sid (b)(6) = 1464.63 iu/l, (b)(6) 2020 sid (b)(6) = 1377.53 iu/l, (b)(6) 2020 sid (b)(6)= 1522.88 iu/l, (b)(6)2020 sid (b)(6) = 1520.55 iu/l.Another architect: (b)(6) 2020 sid (b)(6) = 1214.11 miu / ml, (b)(6) 2020 ¿ sid (b)(6) = 991.33 miu / ml, (b)(6) 2020 ¿ sid (b)(6) = 987.01 miu / ml.Test performed at another laboratory = negative; sample from (b)(6) 2020 tested on the advia centaur = negative.A d&c was performed due to the false positive architect results.A dilation & curettage (d&c) was performed due to the false positive architect results.
|
|
Manufacturer Narrative
|
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, device history record review, field data review and inhouse testing of retained kits with the complaint lot number.Trending review determined no trends for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot.Inhouse testing determined that the accuracy performance is not negatively impacted.The overall performance of architect total b-hcg reagents in the field was reviewed using data gathered via abbottlink from customers worldwide and suggested that the performance of the lot is acceptable.Return testing was not completed as returns were not available.Based on our investigation, we have determined that there is no a systemic issue and/or product deficiency with architect total b-hcg reagent lot 18139ui00.
|
|
Search Alerts/Recalls
|
|
|