MAUDE Adverse Event Report: ALERE SAN DIEGO, INC MEDLINE STREP A TEST STRIP; STREP A RAPID TEST STRIP

Model Number	IST-501
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: MEDLINE STREP A TEST STRIP
• Common Device Name: STREP A RAPID TEST STRIP
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7720546
• Report Number: 2027969-2018-00093
• Device Sequence Number: 16506952
• Product Code: GTY
• UDI-Device Identifier: 30888277191888
• UDI-Public: (01)30888277191888(17)191231(10)STA8010024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: IST-501
• Device Lot Number: STA8010024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR