MEDLINE STREP A TEST STRIP IST-501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-25 for MEDLINE STREP A TEST STRIP IST-501 manufactured by Alere San Diego, Inc.

Event Text Entries

[115370936] Investigation conclusion: retention and returned products for the reported lot number were tested with positive samples (2. 5e07 org/ml). Results were read at 5 minutes and all strips showed expected positive results. Manufacturing batch record review did not uncover any abnormalities. Case details indicate swabs included in the kit were not used for sample collection. Swabs from other manufacturers have not been validated for use with this test. This cannot be ruled out as a possible root cause fro the reported issue. 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


[115370937] The issue was initially reported by the distributor. On (b)(6) 2018, the patient arrived at the facility with an itchy, sore throat and a cough that had been occurring for two weeks. The patient also had swollen lymph nodes and red ulcers on tonsils. The patient was tested with a medline strep a test strip using a dual swab technique and a negative strep a result was obtained. The customer stated a bactiswab was used for the test instead of the kitted medline strep a test strip swab. The customer stated the swab used was sterile but was unable to confirm if rayon transport swabs containing modified stuart's or amies liquid medium were used. A confirmatory culture was also performed using a bactiswab and later produced a positive strep a result (the date of the strep a culture result could not be provided per the customer). Per the customer, the patient also tested positive for mononucleosis (mono). On (b)(6) 2018, the patient still had a sore throat and fatigue. The patient was prescribed 500 mg of penicillin vk, 2x/day for 10 days based off the positive culture report. Per the customer, although the patient was delayed in receiving treatment due to the medline strep a test strip result, no adverse patient outcome occurred. Troubleshooting was conducted with the customer. The customer was advised to use validated swabs (rayon transport swabs containing modified stuart's or amies liquid medium). Furthermore it was recommended that a single swab method be employed when using a medline strep a test strip test.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2018-00093
MDR Report Key7720546
Report SourceDISTRIBUTOR
Date Received2018-07-25
Date of Report2018-07-25
Date of Event2018-05-02
Date Mfgr Received2018-06-26
Date Added to Maude2018-07-25
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 NameMEDLINE STREP A TEST STRIP
Generic NameSTREP A RAPID TEST STRIP
Product CodeGTY
Date Received2018-07-25
Returned To Mfg2018-07-09
Model NumberIST-501
Lot NumberSTA8010024
Device Expiration Date2019-12-31
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 2018-07-25

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