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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMBO PREGNANCY (CATALOGUE NUMBER FHC-202); HCG PREGNANCY TEST
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COMBO PREGNANCY (CATALOGUE NUMBER FHC-202); HCG PREGNANCY TEST Back to Search Results
Catalog Number FHC-202
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/13/2016
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: the customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml and 100 miu/ml hcg urine controls.The results for both the control levels showed positive at read time and met qc specifications.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
 
Event Description
The distributor reported a false negative hcg result for a patient using a combo pregnancy test (catalogue number fhc-202).The patient was tested the same day with a serum hcg result of 340 miu/ml.The part number was not provided by the distributor.
 
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Brand Name
COMBO PREGNANCY (CATALOGUE NUMBER FHC-202)
Type of Device
HCG PREGNANCY TEST
Manufacturer Contact
ya-ling king
9975 summers ridge road
san diego, CA 92121
8588052084
MDR Report Key6087603
MDR Text Key59734585
Report Number2027969-2016-00669
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K993065
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFHC-202
Device Lot NumberHCG6010124
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/13/2016
Initial Date FDA Received11/08/2016
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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