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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

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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 11/09/2020
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.
 
Event Description
The customer reported false positive architect total b-hcg results on a (b)(6)year old female patient who was diagnosed with ectopic pregnancy.Results provided for this architect analyzer, reagent lot 12124ui03: (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.Results on a different architect analyzer, reagent lot 18139ui00: (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.Test performed at another laboratory = negative; sample from (b)(6) 2020 tested on the advia centaur = negative.A d&c was performed on (b)(6) 2020 due to the false positive architect results.A diagnostic laparoscopy was performed on (b)(6) 2020 which confirmed the patient did not have an ectopic pregnancy.
 
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 in house testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.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.In house 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.Based on the investigation, it was determined that there is no a systemic issue or product deficiency with architect total b-hcg reagent lot 12124ui03.
 
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Brand Name
ARCHITECT TOTAL B-HCG REAGENT KIT
Type of Device
SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford N39E9 32
EI  N39E932
MDR Report Key10971882
MDR Text Key221786417
Report Number3005094123-2020-00278
Device Sequence Number1
Product Code DHA
UDI-Device Identifier00380740014964
UDI-Public00380740014964
Combination Product (y/n)N
PMA/PMN Number
K983424
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/08/2021
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
Device Operator Health Professional
Device Expiration Date01/21/2021
Device Model Number7K78-25
Device Catalogue Number07K78-25
Device Lot Number12124UI03
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/26/2020
Initial Date FDA Received12/08/2020
Supplement Dates Manufacturer Received02/08/2021
Supplement Dates FDA Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age45 YR
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