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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG COMBO CASSETTE; HCG PREGNANCY TEST
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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 01/27/2014
Event Type  malfunction  
Event Description
Caller reported a potential false negative urine hcg with consult diagnostics hcg combo cassette.A female pt in her mid twenties was tested with the consult diagnostics hcg combo cassette and results were negative.The pt took a home pregnancy test with positive results.Her last menstrual period was 4 weeks prior to the testing with consult diagnostics hcg combo cassette.The physician's diagnosis was 4 week pregnancy.Physician did not make therapeutic decision based on the test result with the consult diagnostics hcg combo cassette.Test procedure with the consult diagnostics hcg combo cassette was strictly by the product insert.Pt was not taking medications; no physical conditions.
 
Manufacturer Narrative
Investigation pending.
 
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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 Key3829373
MDR Text Key4405456
Report Number2027969-2014-00220
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 02/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2014
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 NumberHCG2110027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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