PRO ADVANTAGE STREP A DIPSTICK (25T) P080033

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-20 for PRO ADVANTAGE STREP A DIPSTICK (25T) P080033 manufactured by Alere San Diego, Inc..

Event Text Entries

[136889124] Investigation pending.
Patient Sequence No: 1, Text Type: N, H10


[136889125] Unspecified date: patient presented to emergency room with symptoms consistent with strep. A throat culture was collected using a dual swab technique and tested on the proadvantage strep a kit which provided a (b)(6) result. No treatment was provided based on the (b)(6) result. The alternate swab was sent for confirmatory testing on the same day, however, the results were not obtained until a few days later. The result of the confirmatory culture was (b)(6). Although further information was requested, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2019-00024
MDR Report Key8356194
Report SourceHEALTH PROFESSIONAL
Date Received2019-02-20
Date of Report2019-05-08
Date Mfgr Received2019-04-22
Date Added to Maude2019-02-20
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 ContactYA-LING KING
Manufacturer Street9975 SUMMERS RIDGE RD.
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8588052084
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRO ADVANTAGE STREP A DIPSTICK (25T)
Generic NameSTREP A RAPID TEST STRIP
Product CodeGTY
Date Received2019-02-20
Model NumberP080033
Lot NumberSTA8050080
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO, INC.
Manufacturer Address9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-20

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