MAUDE Adverse Event Report: ALERE SAN DIEGO, INC CONSULT STREP A DIPSTICK 4999 50T; STREP A RAPID TEST STRIP

Model Number IST-511

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chemical Exposure (2570)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: the corresponding package insert and the msds states to wear protective clothing, disposable gloves and eye protection when using the product.The customer failed to adhere to the instructions included in the labeling.Additionally, the package insert include the following warnings: warning: reagent 1 is harmful if swallowed or absorbed through skin.May cause eye irritation; caution: reagent 2 may cause skin, eye and respiratory tract irritation.Reagent a contains sodium nitrite and reagent b contains acetic acid.If the skin comes in contact with these reagents, the affected area should be thoroughly washed with water.There is no significant immediate health risk to operator/user provided the user should be well protected in accordance with the package insert as msds.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The customer reported that a few drops of reagent 1 and 2 solution from consult strep a dipstick test splashed out of the extraction tube and onto her hand.The customer was not wearing disposable gloves as instructed in the package insert.The customer immediately flushed the affected area with a large amount of water.Although no subsequent injury was reported, this event is being conservatively filed as the solution may be harmful if absorbed through the skin per corresponding labeling.

• Brand Name: CONSULT STREP A DIPSTICK 4999 50T
• 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: 7069311
• MDR Text Key: 93293682
• Report Number: 2027969-2017-00175
• Device Sequence Number: 1
• Product Code: GTY
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IST-511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other