FDA Adverse Event Injury Summary report: N

PRODIGY METER

MDR report key: 1944119 · Received December 27, 2010

Report

Report Number
MW5018746
Event Type
Injury
Date Received
December 27, 2010
Date of Event
December 26, 2010
Report Date
December 27, 2010
Manufacturer
DIAGNOSTIC DEVICES, INC.
Product Code
NBW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

(B)(6) IS A (B)(6) WITH TYPE 1 DIABETES. HE USES THE PRODIGY METER, BECAUSE THIS IS THE ONLY APPROVED METER FOR HIM DUE TO HIS INSURANCE. LAST NIGHT, HE HAD A DIABETIC SEIZURE DUE TO A LOW BLOOD SUGAR. IT TURNS OUT THE METER WAS READING 92 AND HIS SUGAR WAS 50. HE WAS CONVULSING AND SEIZING FOR 5 TO 10 MINUTES, AND I HAD TO CALL 911, HE HAD TO RIDE IN AN AMBULANCE TO (B)(6) HOSPITAL, WHICH IS CLOSEST TO OUR HOUSE. (B)(6) WAS WATCHING A MOVIE IN THE LIVING ROOM AT HOME WITH HIS OLDER BROTHERS, WHEN HE STARTED STRANGE MOVEMENTS AND MAKING LOUD NOISES. HIS BROTHER RAN INTO MY ROOM TO GET ME.. TO TELL ME THAT SOMETHING WAS WRONG, SO I RAN INTO THE LIVING ROOM AND SAW WHAT WAS HAPPENING TO (B)(6). IT WAS ABOUT 10PM AT NIGHT, I CHECKED HIS SUGAR RIGHT THEN, IT SAID 60, BUT IT MUST HAVE BEEN MORE LIKE 20 - BECAUSE EVERY TIME THEY CHECKED HIS SUGAR AT THIS HOSPITAL, I CHECKED HIS SUGAR WITH THE PRODIGY METER, EACH TIME HIS SUGAR WAS READING ABOUT 20 TO 40 POINTS DIFFERENT-HIGHER- ON THE PRODIGY, THAN THE HOSPITAL'S METER. THIS IS A HUGE PROBLEM, (B)(6) COULD HAVE DIED BECAUSE FALSE READINGS FROM THE PRODIGY METER!!!!! THE PRODIGY METER HAS TO BE RECALLED BEFORE A CHILD DOES DIE.... (SAME PT REFERRED TO IN (B)(4)). DIAGNOSIS OR REASON FOR USE: TYPE 1 DIABETES. EVENT ABATED AFTER USE: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PRODIGY METER PRODIGY METER NBW DIAGNOSTIC DEVICES, INC.

Patients

Seq Age Sex Outcome Treatment
1 6 YR Hospitalization| L| O| S PRODIGY METER, DIAGNOSTIC DEVICES, INC.