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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 Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed a false negative architect total b-hcg result for one patient.The architect total b-hcg result was negative (1.0 miu/ml).The same sample was cross checked at other lab result obtained was <1.20.The patient had testing done at a different facility and the result was positive; additionally, the pregnancy was confirmed by sonography.No adverse impact to patient management was reported.No adverse impact to patient management was reported.
 
Manufacturer Narrative
This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.
 
Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot indicates that the reagent lot shows normal complaint activity.Return testing was not performed as returns were not available.Device history record review was performed on lot 35045ud00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.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.Based on all reviewed data, we conclude that there is no product deficiency with the architect total ss-hcg reagent identified in this complaint.
 
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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
Manufacturer (Section G)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford N39E9 32
EI   N39E932
Manufacturer Contact
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key15176335
MDR Text Key301217886
Report Number3005094123-2022-00164
Device Sequence Number1
Product Code DHA
UDI-Device Identifier00380740014964
UDI-Public00380740014964
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K983424
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/05/2023
Device Model Number7K78-25
Device Catalogue Number07K78-25
Device Lot Number35045UD00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/18/2022
Initial Date FDA Received08/05/2022
Supplement Dates Manufacturer Received09/06/2022
10/26/2022
Supplement Dates FDA Received09/28/2022
11/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC I1000SR INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)
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