FDA Adverse Event Injury Summary report: N

MEDTRONIC PUMP INFUSION SETS

MDR report key: 1418545 · Received July 18, 2009

Report

Report Number
MW5012039
Event Type
Injury
Date Received
July 18, 2009
Date of Event
June 6, 2009
Report Date
July 18, 2009
Manufacturer
MEDTRONIC
Product Code
FPA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

ON TWO DIFFERENT OCCASIONS, BTG, MY SON LISTED ABOVE HAD TWO SERIOUS HYPOGLYCEMIC EPISODES THAT WERE UNEXPLAINABLE. FOR UNKNOWN REASONS, HIS BLOOD GLUCOSE DROPPED TO SEVERE LOW LEVELS. HE HAD TO BE HELPED TWICE BY HIS COLLEGE ROOM MATE TO GET HIS BLOOD GLUCOSE LEVELS BACK FROM LIFE THREATENING LEVELS. WITHOUT HIS ROOM MATE BEING AVAILABLE, BTG WOULD NOT BE ALIVE TODAY OR ALIVE DEALING WITH SERIOUS COMPLICATIONS. EACH TIME HE HAD EATEN A LARGE MEAL PRIOR TO BEDTIME, GAVE HIS USUAL BOLUS AND WENT TO BED WITH THE SECURITY OF KNOWING THAT HE WOULD BE SAFE. HOWEVER, HIS BLOOD GLUCOSE WOULD BE SO LOW IN THE AM THAT HE WAS ON THE BRINK OF UNRESPONSIVENESS. HIS PUMP WOULD BE DISCONNECTED EACH TIME, INTERVENTIONS GIVEN, AND THEN HE WOULD SLOWLY RETURN TO BASE LINE. BUT, AS I MENTIONED, HE NOR ANYONE ELSE COULD EXPLAIN WHAT HAD HAPPENED AND WHY SINCE HE DID NOT OVER BOLUS FOR EACH MEAL. IN FACT, ONE TIME, HE WAS SITTING AND WATCHING TELEVISION WHEN HE HAD AN EPISODE. THIS HAD NEVER HAPPENED BEFORE. EACH TIME, HE WOULD CHANGE HIS ENTIRE PUMP ACCESSORIES 'JUST IN CASE' THERE WAS A PROBLEM. WE WERE ALL AT A LOSS OF WHAT HAD CAUSED SUCH A DRASTIC LIFE THREATENING CHANGE UNTIL WE GOT THE RECALL NOTICE FOR PUMP SUPPLIES FROM MEDTRONIC. THE INFUSION SETS RECALLED ARE THE SAME ONE THAT BTG USES. WE NOW CAN PUT A CAUSE BEHIND THE INCIDENTS MENTIONED. I BELIEVE THAT THESE SETS WERE THE CAUSE AND BTG IS VERY LUCKY TO BE ALIVE. DATES OF USE: CONTINUAL. DIAGNOSIS OR REASON FOR USE: DIABETIC. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC PUMP INFUSION SETS NONE FPA MEDTRONIC 8

Patients

Seq Age Sex Outcome Treatment
1 20 YR Life Threatening| O| S