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: ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG COMBO CASSETTE; HCG PREGNANCY TEST
  • 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
 

ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG COMBO CASSETTE; HCG PREGNANCY TEST Back to Search Results
Model Number FHC-A202-OBC554
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2014
Event Type  malfunction  
Event Description
Customer reported potential false negative urine hcg results with consult diagnostics hcg combo cassette vs.Ultrasound.Customer reported that a (b)(6) year old female pt's urine sample was run three times with consult diagnostics hcg combo cassette giving negative results each time.The pt's last menstrual period was on (b)(6) 2013.No quantitative testing was performed but diagnosis that pt was 9 weeks pregnant was based on ultrasound.No treatment was provided based on the negative results.The customer noted that external controls were run without issue; normal/expected results obtained.
 
Manufacturer Narrative
Investigation pending.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONSULT DIAGNOSTICS HCG COMBO CASSETTE
Type of Device
HCG PREGNANCY TEST
Manufacturer (Section D)
ALERE SAN DIEGO, INC.
san diego CA
Manufacturer Contact
ya-ling king
9975 summers ridge rd
san diego, CA 92121
8588052084
MDR Report Key3856954
MDR Text Key4660557
Report Number2027969-2014-00116
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFHC-A202-OBC554
Device Lot NumberHCG3010013
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/04/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/22/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
TIROSINT
Patient Age36 YR
-
-