FISHER - SURE-VUE HCG URINE CASS. (30T) FHC-A202 23900531

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-12 for FISHER - SURE-VUE HCG URINE CASS. (30T) FHC-A202 23900531 manufactured by Alere San Diego.

Event Text Entries

[188825742] Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples. The results were read at 3 and 4 minutes, and all devices yielded the expected negative results. No false positive results were observed during in-house testing. The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified. Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications. Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified. A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product. Per the package insert, this test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
Patient Sequence No: 1, Text Type: N, H10


[188825763] The customer checked the hcg test result after 3 minutes observing a false positive result. A control line was present with a clear line in the test region and a pink background. A second urine pregnancy test was done with the same result. A blood sample tested at a lab confirmed results to be negative for pregnancy. This file is associated with 2027969-2020-00006.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2020-00007
MDR Report Key9827542
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-03-12
Date of Report2020-03-10
Date of Event2020-02-20
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-12
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 NameFISHER - SURE-VUE HCG URINE CASS. (30T)
Generic NameHCG PREGNANCY TEST
Product CodeJHI
Date Received2020-03-12
Model NumberFHC-A202
Catalog Number23900531
Lot NumberHCG9072032
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO
Manufacturer Address9975 SUMMERS RIDGE RD SAN DIEGO, CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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