FDA Adverse Event Injury Summary report: N

FREESTYLE FREEDOM LITE

MDR report key: 2951120 · Received February 8, 2013

Report

Report Number: 2954323-2013-00087
Event Type: Injury
Date Received: February 8, 2013
Date of Event: January 6, 2013
Report Date: January 16, 2013
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. IT SHOULD BE NOTED THAT CUSTOMER WAS USING EXPIRED TEST STRIPS (EXPIRATION DATE 31 MARCH, 2012).

Description of Event or Problem · 1

CUSTOMER REPORTED RECEIVING AN UNSPECIFIED READING ON HIS ADC METER THAT WAS LOWER THAN HE FELT (UNKNOWN DATE AND TIME). CUSTOMER FURTHER REPORTED THAT ON (B)(6), 2013 HE RECEIVED A READING OF 300 MG/DL WHICH WAS HIGHER THAT HE FELT. CUSTOMER ALSO STATED THAT A READING OF 400 MG/DL OBTAINED ON HIS ADC METER WAS LOWER THAN A READING OF 600 MG/DL OBTAINED ON UNKNOWN BRAND HCP METER; HOWEVER, NO DATE OR TIME WAS PROVIDED FOR THESE READINGS. CUSTOMER STATED THAT ON (B)(6) 2013, HE EXPERIENCED SYMPTOMS THAT WERE DESCRIBED AS "DEHYDRATION" AND NEEDED TO INCREASE "HIS INSULIN SHOTS". CUSTOMER STATED THAT HE HAD A LOSS OF CONSCIOUSNESS AND SEIZURE. IT IS UNKNOWN WHETHER CUSTOMER SELF-TREATED. PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH "ANTIBIOTICS". CUSTOMER REPORTED THAT HE WAS HOSPITALIZED AND RECEIVED A DIAGNOSIS OF HYPERGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
54079	FREESTYLE FREEDOM LITE	BLOOD GLUCOSE MONITORING SYSTEM	NBW			1076803

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Hospitalization\| O\| R