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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. THE SUPPLY EXPERTS HCG URINE - CASSETTE; HCG PREGNANCY TEST
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ALERE SAN DIEGO, INC. THE SUPPLY EXPERTS HCG URINE - CASSETTE; HCG PREGNANCY TEST Back to Search Results
Model Number FHC-102-OBW01
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2014
Event Type  malfunction  
Event Description
Customer alleges potential false negative hcg results using the supply experts hcg urine - cassette.Patient self tested at home using an unknown over the counter (otc) kit and received a positive result.Result in office using the supply experts hcg urine - cassette was negative.Quantitative blood result was not available.The testing time was after 10 am.The physician diagnosed patient as pregnant by clinical and ultrasound.Kit storage: room temp.External control: normal.Procedure: verified by tss.Other patient results: normal as expected.There was no reported adverse event.No additional information was provided.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
THE SUPPLY EXPERTS HCG URINE - 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 Key3853848
MDR Text Key20784347
Report Number2027969-2014-00355
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2015
Device Model NumberFHC-102-OBW01
Device Lot NumberHCG3070036
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/02/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2014
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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