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 2018-07-12 for CONSULT STREP A DIPSTICK 5003 25T IST-501 manufactured by Alere San Diego, Inc.

Event Text Entries

[114159733] Investigation conclusion: retention products of lot sta7100031 were tested with 29 strips using 2. 5e07org/ml positive sample. Read time was at 5 minutes. The testing results indicated that all 29 strips showed correct positive results. This lot met qc specifications. The complaint was not replicated with in-house retain product. No false negative results were obtained during in-house testing. The returned product of lot sta7100031 was tested in replicate of 8 strips with 2. 5e07org/ml positive sample. Read time was at 5 minutes. The testing results indicated that all 8 strips showed correct positive results and all of the results met qc specification. The returned product testing indicated the product performed as expected with 2. 5e07org/ml positive sample. The customer's observation was not replicated. Manufacturing batch record review did not uncover any abnormalities. A negative result may be obtained if the concentration of the strep a antigen present in the throat swab is not adequate or is below the detectable level of the test. 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


[114159734] On (b)(46 2018, the patient presented at the facility with a sore throat, fever, and vomiting. A consult strep a dipstick test using a dual swab technique produced a negative strep a result. A confirmatory culture was also performed and later produced a positive strep a result (the date of the strep a culture result could not be provided per the customer). On (b)(6) 2018, the patient was prescribed 400 mg of amoxicillin for 10 days based on the confirmatory culture. Per the customer, the patient was delayed in receiving treatment due to the consult strep a dipstick test result. No adverse patient outcome reported. Troubleshooting was conducted with the customer. It was recommended that a single swab method be employed as the swab used for the consult strep a dipstick test may contain antigen below the level of detection for the test.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2018-00089
MDR Report Key7684079
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2018-07-12
Date of Report2018-07-12
Date of Event2018-06-07
Date Mfgr Received2018-06-13
Date Added to Maude2018-07-12
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 Received2018-07-12
Returned To Mfg2018-06-21
Model NumberIST-501
Lot NumberSTA7100031
Device Expiration Date2019-10-31
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 2018-07-12

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