MAUDE Adverse Event Report: ALERE SAN DIEGO, INC CONSULT STREP A DIPSTICK 5003 25T; 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 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: CONSULT STREP A DIPSTICK 5003 25T
• 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: 7684079
• MDR Text Key: 114159733
• Report Number: 2027969-2018-00089
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 20612479202737
• UDI-Public: (01)20612479202737(17)191031(10)STA7100031
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: IST-501
• Device Lot Number: STA7100031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Date Manufacturer Received: 06/13/2018
• 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: 8 YR