MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. KETOSTIX; KETONE REAGENT STRIPS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

The patient/family was the initial reporter.As no product details are available, device manufacturer date could not be determined.

Event Description

The customer reported that he had an allergic reaction with ketostix.No further event details were provided.The test strips are not expected to be returned.

• Brand Name: KETOSTIX
• Type of Device: KETONE REAGENT STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; registration # 3011121740; 5 wood hollow road; parsippany NJ 07054
• Manufacturer (Section G): ASCENSIA DIABETES CARE US INC.; registration # 3011121740; 5 wood hollow road; parsippany NJ 07054
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142962901
• MDR Report Key: 8138457
• MDR Text Key: 129569832
• Report Number: 1810909-2018-00096
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• PMA/PMN Number: K801270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1