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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO HCG ONE STEP PREGNANCY TEST DEVICE (URINE); HCG PREGNANCY TEST
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ALERE SAN DIEGO HCG ONE STEP PREGNANCY TEST DEVICE (URINE); HCG PREGNANCY TEST Back to Search Results
Model Number FHC-102B-OBC01
Device Problem False Negative Result (1225)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/26/2014
Event Type  malfunction  
Event Description
Distributor reported potential false negative urine hcg result on one pt vs.Ultrasound.A women pregnant in week 11 plus 2 days arrived with genital bleeding.She was tested with hcg one step pregnancy test device (urine) and the result was negative.They then decided to do an ultrasound examination which confirmed that this woman was still pregnant.No further info was available.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
Type of Device
HCG PREGNANCY TEST
Manufacturer (Section D)
ALERE SAN DIEGO
san diego CA
Manufacturer Contact
ya-ling king
9975 summers ridge rd.
san diego, CA 92121
8588052084
MDR Report Key3866445
MDR Text Key15324167
Report Number2027969-2014-00366
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K993317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/26/2014
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 Model NumberFHC-102B-OBC01
Device Lot NumberHCG3060143
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/04/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/26/2014
Initial Date FDA Received04/23/2014
Was Device Evaluated by Manufacturer? No
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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