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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INNOVACON HCG URINE (40 PER/BX); HCG PREGNANCY TEST
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INNOVACON HCG URINE (40 PER/BX); HCG PREGNANCY TEST Back to Search Results
Model Number IVFHC-102-ICBC01
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2016
Event Type  malfunction  
Manufacturer Narrative
The customer did not provide a lot number or return any products for investigation.Since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.
 
Event Description
Customer reported potential false negative urine hcg results with innovacon hcg urine test vs.Results confirmed positive by blood test.The patient was tested using innovacon pregnancy test which gave negative results at three minutes.At about 10 minutes the test was positive.Blood was taken and confirmed positive; no actual result was provided; the patient was about (b)(6) pregnant.Although requested, no further information was provided.
 
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Brand Name
INNOVACON HCG URINE (40 PER/BX)
Type of Device
HCG PREGNANCY TEST
Manufacturer Contact
ya-ling king
9975 summers ridge rd.
san diego, CA 92121
8588052084
MDR Report Key5699269
MDR Text Key46570665
Report Number2027969-2016-00420
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 foreign,health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIVFHC-102-ICBC01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2016
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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