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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SHEIN ONE STEP+ HCG URINE CASSETTE TEST; HCG PREGNANCY TEST
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ALERE SAN DIEGO, INC. HENRY SHEIN ONE STEP+ HCG URINE CASSETTE TEST; HCG PREGNANCY TEST Back to Search Results
Model Number FHC-102-KHS25
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2014
Event Type  malfunction  
Event Description
Caller reported a potential false negative urine hcg result with henry schein one step+ hcg urine cassette test vs.Serum hcg result.A urine sample from a (b)(6) old female pt was tested using henry schein one step+ hcg urine cassette test with a negative result.The patient's blood was tested with beta hcg result of 128,786miu/ml, the patient's last menstrual period was (b)(6) 2013.No treatment was administered after the negative result; the provider waited for the results of the blood test.No further details were available.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
HENRY SHEIN ONE STEP+ HCG URINE CASSETTE TEST
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 Key3720727
MDR Text Key14880040
Report Number2027969-2014-00167
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 Health Care Professional
Type of Report Initial
Report Date 02/03/2014
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-102-KHS25
Device Lot NumberHCG3050296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2014
Initial Date FDA Received02/24/2014
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
Patient Age17 YR
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