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

Model Number IST-501

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

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 Description

The issue was initially reported by the distributor.On (b)(6) 2018, the patient arrived at the facility with a sore throat that had been occurring for three days.The patient reported exposure to strep and presented with a red throat and tonsil enlargement.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).On (b)(6) 2018, the patient reported "feeling better" prior to treatment.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
• Type of Device: STREP A RAPID TEST STRIP
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 7720668
• MDR Text Key: 115358117
• Report Number: 2027969-2018-00095
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 30888277191888
• UDI-Public: (01)30888277191888(17)191231(10)STA8010024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR