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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
Catalog Number 07K78-74
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
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.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
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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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 Key14214681
MDR Text Key290188505
Report Number3005094123-2022-00087
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 07/14/2022
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 Date08/18/2022
Device Catalogue Number07K78-74
Device Lot Number31141UD02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/06/2022
Initial Date FDA Received04/26/2022
Supplement Dates Manufacturer Received07/11/2022
Supplement Dates FDA Received07/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC I2000SR INST, 03M74-02, ISR63757.; ARC I2000SR INST, 03M74-02, ISR63757.
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