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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG CASSETTE (25); HCG PREGNANCY TEST
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ALERE SAN DIEGO, INC. ALERE HCG CASSETTE (25); HCG PREGNANCY TEST Back to Search Results
Model Number 92217
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2014
Event Type  malfunction  
Event Description
Customer called alleged receiving report from e.R.Citing 1 patient clear urine tested at room temp, following standard procedure, hcg was negative.Since patient has already been diagnosed by ultrasound as 20 weeks pregnant, a urine test using quickview by the lab and result was clearly positive.Patient was admitted to e.R.For "abnormal pain".Patient health and pregnancy not comprised by the false result on alere hcg test.The urine sample was disposed by the lab.No blood hcg test performed.Product not available for return.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
ALERE HCG CASSETTE (25)
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 Key3720725
MDR Text Key16800674
Report Number2027969-2014-00164
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993317
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 02/10/2014
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 Number92217
Device Lot NumberHCG3080101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/10/2014
Initial Date FDA Received02/24/2014
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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