FDA Adverse Event Injury Summary report: N

PRECISION XTRA

MDR report key: 1984346 · Received February 10, 2011

Report

Report Number: 2954323-2011-01579
Event Type: Injury
Date Received: February 10, 2011
Date of Event: January 11, 2011
Report Date: April 7, 2011
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

Additional Manufacturer Narrative · 1

REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

Description of Event or Problem · 1

CUSTOMER REPORTED RECEIVING READINGS OF 312 MG/DL AND 177 MG/L ON HIS PRECISION XTRA BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN HE FELT. HE FURTHER REPORTED SELF-DOSING WITH AN UNKNOWN AMOUNT OF INSULIN IN RESPONSE TO THE READINGS AND SUBSEQUENTLY EXPERIENCED LIGHTHEADEDNESS, DIAPHORESIS AND TREMULOUSNESS, WHICH RESULTED IN A LOSS OF CONSCIOUSNESS. CUSTOMER WAS UNABLE TO STATE WHEN THIS EVENT OCCURRED, BUT HE THOUGHT IT WAS IN (B)(6) 2010. PARAMEDICS WERE CALLED, ADMINISTERED GLUCOSE VIA AN INTRAVENOUS INFUSION AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY. CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH ADDITIONAL INTRAVENOUS GLUCOSE. CUSTOMER ALSO SELF-TREATED BY DRINKING JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRECISION XTRA	BLOOD GLUCOSE MONITORING SYSTEM	NBW			45001A786

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other