A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
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Catalog Number 07K78-74 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2022 |
Event Type
malfunction
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Event Description
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The customer observed false negative architect total b-hcg results for one patient when compared to another method.The architect result was <1.2 iu/ml (reference range 0 to 5 iu/ml), retested <1.2 iu/ml.The customer tested the sample with the gold standard method, and the result was a weak positive.The customer has another new industrial platform that can detect bhcg by chemiluminescence, and this platform has a test result of 0.3 (reference range of 0-10), which is also negative.No impact to patient management was reported.
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Manufacturer Narrative
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Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Return testing was not performed as returns were not available.Device history record review was performed on lot 31141ud02, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Ticket search by lot indicates that the reagent lot shows normal complaint activity.Labeling review concludes that the issue is adequately addressed.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.The customer confirmed eventually that the result was consistent with the patient¿s clinical presentation.Based on the information within the complaint record, results obtained with the reagent were in alignment with clinical presentation.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.Based on all reviewed data, we conclude that there is no product deficiency with the architect total ss-hcg reagent identified in this complaint.Corrected data found in section d3 and g1.
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Search Alerts/Recalls
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