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
  • 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 Back to Search Results
Catalog Number 07K78-74
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/26/2019
Event Type  malfunction  
Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
 
Event Description
The customer observed a false negative b-hcg result on the architect i2000sr analyzer.The following data was provided: initial 0miu/ml.The patient stated that on october 26 she took a urine pregnancy test on her own (immunoblotting method) and the result was positive.On november 21, the patient underwent the hcg test at another hospital with the result being greater than 110000miu/ml.There was no impact to patient management reported.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the design history file, review of field data, and a review of labeling.No adverse trend, non-conformances, potential non-conformances, or deviations were identified for the customer's issue.No return patient sample was available.Labeling was reviewed and found to be adequate.Accurate and reproducible results are dependent upon properly functioning instruments and reagents, storage of product as directed, and good laboratory technique.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARCHITECT TOTAL B-HCG
Type of Device
B-HCG
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford NA
EI  NA
MDR Report Key9379554
MDR Text Key219779926
Report Number3005094123-2019-00345
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/09/2020
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 Date11/16/2019
Device Catalogue Number07K78-74
Device Lot Number93105UI00
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/21/2019
Initial Date FDA Received11/26/2019
Supplement Dates Manufacturer Received01/09/2020
Supplement Dates FDA Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02 SN (B)(6) ; LN 03M74-02 SN (B)(6)
-
-