CONSULT HCG URINE CASSETTE 5001 25T FHC-A102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-02-19 for CONSULT HCG URINE CASSETTE 5001 25T FHC-A102 manufactured by Alere San Diego.

Event Text Entries

[188844759] Results pending completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[188844760] A customer reported that a patient had a false positive test on (b)(6) 2020 with a same day confirmatory blood test at a lab that was negative, beta quant <1. A retest occurred on an hcg kit with a urine sample on (b)(6) 2020 and it was negative. The patient was not impacted by the outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2020-00005
MDR Report Key9727909
Report SourceDISTRIBUTOR,USER FACILITY
Date Received2020-02-19
Date of Report2020-02-18
Date of Event2020-01-29
Date Mfgr Received2020-02-07
Date Added to Maude2020-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMONIKA BURRELL
Manufacturer Street9975 SUMMERS RIDGE ROAD
Manufacturer CitySAN DIEGO, CA
Manufacturer CountryUS
Manufacturer Phone8052506
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONSULT HCG URINE CASSETTE 5001 25T
Generic NameHCG PREGNANCY TEST
Product CodeJHI
Date Received2020-02-19
Model NumberFHC-A102
Lot NumberHCG9010105
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO
Manufacturer Address9995 SUMMERS RIDGE RD SAN DIEGO, CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.