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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSULT HCG DIPSTICK TEST 5000 25T; HCG PREGNANCY TEST
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CONSULT HCG DIPSTICK TEST 5000 25T; HCG PREGNANCY TEST Back to Search Results
Model Number FHC-101-OBC517
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
It is indicated that no product is available for return from the customer.Additionally, the customer was unable to provide a lot number for the complaint product.As no lot number was provided, testing with reserve sample from same lot and a manufacturing batch record review could not be conducted.No further investigation can be pursued at this time and no corrective action is required.
 
Event Description
The customer reported a false negative hcg result for a patient using a consult hcg dipstick test 5000 25t.The urine sample collected for the consult hcg dipstick test was not a first morning urine sample.No additional information, including information on confirmatory testing, is available per the customer.The customer was unable to provide the lot number of the product used.
 
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Brand Name
CONSULT HCG DIPSTICK TEST 5000 25T
Type of Device
HCG PREGNANCY TEST
Manufacturer Contact
ya-ling king
9975 summers ridge road
san diego, CA 92121
8588052084
MDR Report Key6110144
MDR Text Key60300551
Report Number2027969-2016-00684
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/03/2016
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-101-OBC517
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2016
Initial Date FDA Received11/17/2016
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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