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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN ONE STEP+ HCG COMBO TEST; HCG/PREGNANCY
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ALERE SAN DIEGO, INC. HENRY SCHEIN ONE STEP+ HCG COMBO TEST; HCG/PREGNANCY Back to Search Results
Model Number FHC-202-KHS25
Device Problem False Negative Result (1225)
Patient Problem No Information (3190)
Event Date 10/01/2014
Event Type  malfunction  
Event Description
Caller alleged false negative hcg results for one pt.Results as follows: date of event: (b)(6) 2014.Time of urine collection: 4:20 pm.Last menstrual period: unk.Quantitative serum hcg result: 164.Specific gravity: 1.025.Pt had a miscarriage prior to testing on 10/1.Customer was testing to make sure the hcg levels were decreasing.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
HENRY SCHEIN ONE STEP+ HCG COMBO TEST
Type of Device
HCG/PREGNANCY
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 Key4172193
MDR Text Key5161305
Report Number2027969-2014-00916
Device Sequence Number1
Product Code JHI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993065
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFHC-202-KHS25
Device Lot NumberHCG4010107
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/03/2014
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
Treatment
MEDICATION: IBUPROFEN
Patient Age43 YR
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