FDA Adverse Event Injury Summary report: N

FREESTYLE INSULINX

MDR report key: 3885085 · Received June 19, 2014

Report

Report Number: 2954323-2014-00696
Event Type: Injury
Date Received: June 19, 2014
Date of Event: May 28, 2013
Report Date: May 28, 2014
Product Code: NBW
PMA / PMN Number: K120568
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED PRODUCT WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

Additional Manufacturer Narrative · 1

THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. THE DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. IT SHOULD BE NOTED: DURING TROUBLESHOOTING IT WAS REVEALED THE CUSTOMER WAS USING FS LITE TEST STRIPS WITH HER FS INSULINX METER. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT APPROXIMATELY ONE YEAR AGO SHE RECEIVED AN UNSPECIFIED READING (CUSTOMER CANNOT REMEMBER THE ACTUAL READING RECEIVED) ON HER ADC BLOOD GLUCOSE METER WHICH WAS HIGHER THAN SHE FELT. CUSTOMER FURTHER REPORTED EXPERIENCING "SWEATING", SUBSEQUENTLY LOST CONSCIOUSNESS AND FELL DOWN. PARAMEDICS WERE CALLED AND TREATED THE CUSTOMER WITH AN UNSPECIFIED "SHOT". THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
361339	FREESTYLE INSULINX	BLOOD GLUCOSE MONITORING SYSTEM	NBW			1454814

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention