CONSULT STREP A DIPSTICK 5003 25T IST-501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-06-29 for CONSULT STREP A DIPSTICK 5003 25T IST-501 manufactured by Alere San Diego, Inc.

Event Text Entries

[112900550] Investigation conclusion: retention and returned products for the reported lot number were tested with asymptomatic clinical samples. Results were read at 5 minutes and at 10 minutes. All strips correctly yielded negative results. No false positive result were observed. Manufacturing batch record review did not uncover any abnormalities. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10


[112900551] On (b)(6) 2018, a (b)(6) patient arrived at the facility with a sore throat. The patient was tested with a consult strep a dipstick test using a dual swab method and a positive strep a result was received. The patient was prescribed amoxicillin 400 mg based on the consult strep a dipstick test and sent home. A culture was performed and was grown on disks specific for group a strep a over a period of 48 hours. On (b)(6) 2018, the customer received the results of the culture. The culture was negative for strep a. The customer contacted the patient/guardian the same day and advised discontinuation of the amoxicillin 400 mg course previously prescribed. The customer was unable to confirm how many days the patient took the medication but stated it could not have been more than two days. The patient was prescribed symptomatic treatment for the sore throat and upon follow-up the patient was reported as "doing fine. " the final diagnosis of the patient was pharyngitis. Troubleshooting was performed with the customer. The customer was advised that saliva and mucous may contribute to the false positive result and that this kit is only validated for use with a single swab technique.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2018-00078
MDR Report Key7651497
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2018-06-29
Date of Report2018-06-29
Date of Event2018-05-14
Date Mfgr Received2018-06-01
Date Added to Maude2018-06-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYA-LING KING
Manufacturer Street9975 SUMMERS RIDGE ROAD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8588052084
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONSULT STREP A DIPSTICK 5003 25T
Generic NameSTREP A RAPID TEST STRIP
Product CodeGTY
Date Received2018-06-29
Returned To Mfg2018-06-21
Model NumberIST-501
Lot NumberSTA7120056
Device Expiration Date2019-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO, INC
Manufacturer Address9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-29

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