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 Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: retention and returned products for the reported lot number were tested with asymptomatic clinical samples.Results were read at 5 minutes and at 10 minutes.All strips correctly yielded negative results.No false positive result were observed.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

On (b)(6) 2018, a (b)(6) patient arrived at the facility with a sore throat.The patient was tested with a consult strep a dipstick test using a dual swab method and a positive strep a result was received.The patient was prescribed cefdinir 250 mg based on the consult strep a dipstick test and sent home.A culture was performed and was grown on disks specific for group a strep a over a period of 48 hours.On (b)(6) 2018, the customer received the results of the culture.The culture was negative for strep a.The customer contacted the patient/guardian the same day and advised discontinuation of the cefdinir 250 mg course previously prescribed.The customer was unable to confirm how many days the patient took the medication but stated it could not have been more than two days.The patient was prescribed symptomatic treatment for the sore throat and upon follow-up the patient was reported as "doing fine." the final diagnosis of the patient was pharyngitis.Troubleshooting was performed with the customer.The customer was advised that saliva and mucous may contribute to the false positive result and that this kit is only validated for use with a single swab technique.

• 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: 7651583
• MDR Text Key: 112899635
• Report Number: 2027969-2018-00079
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 20612479202737
• UDI-Public: (01)20612479202737(17)191130(10)STA7120056
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: IST-501
• Device Lot Number: STA7120056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18