Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

A.I.D.D LONGFORD ARCHITECT TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN Back to Search Results
Model Number 7K78-35
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
Event Description
The customer stated that false negative architect total b-hcg results were generated for patient samples.An inquiry was made by a physician.No specific patient data was provided.No adverse 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.All available patient information was included.Additional patient details are not available.
 
Event Description
The customer stated that false negative architect total b-hcg results were generated for patient samples.An inquiry was made by a physician.No specific patient data was provided.No adverse impact to patient management was reported.
 
Manufacturer Narrative
After further evaluation of the customer issue, the suspect medical device was changed on january 29, 2022.The customer issue was also clarified to be false positive, not false negative.Mdr number 3016438761-2022-00049 has been submitted for the new suspect medical device and all further information will be documented under that mdr number.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key13026660
MDR Text Key285533636
Report Number3005094123-2021-00247
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
Reporter Country CodeBR
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
Report Date 02/01/2022
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 Date05/17/2022
Device Model Number7K78-35
Device Catalogue Number07K78-35
Device Lot Number27541UD00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2021
Initial Date FDA Received12/17/2021
Supplement Dates Manufacturer Received01/29/2022
Supplement Dates FDA Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC I2SR REFURB-BRAZIL, 03M74-56, (B)(6); ARC I2SR REFURB-BRAZIL, 03M74-56, (B)(6)
Patient SexFemale
-
-