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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG DIPSTICK; HCG PREGNANCY TEST
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ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG DIPSTICK; HCG PREGNANCY TEST Back to Search Results
Model Number FHC-101-OBC517
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2014
Event Type  malfunction  
Event Description
Distributor emailed "defective inaccurate results, false negatives" hcg pregnancy test.No patient information or confirmatory lab results were submitted.Numerous calls an faxes were sent to distributor in an attempt to gain additional information; however all attempted contacts were unsuccessful.No reported adverse patient sequela.No additional information provided.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
CONSULT DIAGNOSTICS HCG DIPSTICK
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 Key4239872
MDR Text Key5019131
Report Number2027969-2014-00988
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 Health Professional
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFHC-101-OBC517
Device Lot NumberHCG3010009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2014
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
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