MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. PRO ADVANTAGE STREP A DIPSTICK (25T); STREP A RAPID TEST STRIP

Model Number P080033

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

Unspecified date: young girl presented to er with symptoms consistent with strep.A throat culture was collected using a dual swab technique and tested on the proadvantage strep a kit which provided a negative result.No treatment was provided based on the false negative result.The alternate swab was sent for confirmatory testing on the same day, however, the results were not obtained until three days later.The result of the confirmatory culture was positive.During that three day period, the girl attended school potentially exposing other children to strep.Although further information was requested, no further information was provided.

Manufacturer Narrative

An investigation was performed on retention product from the reported lot number.Retention devices were tested with qc cutoff standards (2.5e07 org/ml).Results were read at 5 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.A root cause could not be determined from the available information as retention product performed as expected during in-house testing.Case details indicate that it is unknown whether the confirmatory culture was specific to strep a.Please note, this device is a qualitative, lateral flow immunoassay for the detection of strep a carbohydrate antigen.Furthermore, 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.Alere san diego will continue to monitor this issue through incoming complaints.

• Brand Name: PRO ADVANTAGE STREP A DIPSTICK (25T)
• Type of Device: STREP A RAPID TEST STRIP
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 8356214
• MDR Text Key: 140320326
• Report Number: 2027969-2019-00022
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Public: +$$3200430STA8050080NR+M220P0800333N
• Combination Product (y/n): N
• PMA/PMN Number: K010582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: P080033
• Device Catalogue Number: P080033
• Device Lot Number: STA8050080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1