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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURESTEP HCG URINE CASSETTE (25T); HCG PREGNANCY TEST
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SURESTEP HCG URINE CASSETTE (25T); HCG PREGNANCY TEST Back to Search Results
Model Number FHC-102
Device Problem False Negative Result (1225)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion.Investigation pending.
 
Event Description
Report received of false negative urine hcg results on surestep hcg urine cassette (25t).Event occurred in (b)(6).Report received that the surestep hcg test did not pass laboratory specificity and sensitivity at 25 miu/ml of hcg.The first round of laboratory testing has been completed in the post-market medical device review of human chorionic gonadotropin (hcg) urine pregnancy test kits.Reportedly, the +plus hcg urine and alere hcg cassette passed laboratory specificity and sensitivity at 25 miu/ml of hcg.However, the surestep device did not.This device was sensitive at 50 miu/ml but not 25 miu/ml.Reportedly, there was no patient involvement.No reported adverse patient sequela.No additional information available.
 
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Brand Name
SURESTEP HCG URINE CASSETTE (25T)
Type of Device
HCG PREGNANCY TEST
Manufacturer Contact
ya-ling king
9975 summers ridge road
san diego, CA 92121
8588052084
MDR Report Key6024204
MDR Text Key57487665
Report Number2027969-2016-00649
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K993317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other
Type of Report Initial
Report Date 09/16/2016
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
Device Lot NumberHCG6030070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/16/2016
Initial Date FDA Received10/12/2016
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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