FDA Adverse Event Malfunction Summary report: N

MEDTRONIC-MINIMED

MDR report key: 472460 · Received July 15, 2003

Report

Report Number
MW1028992
Event Type
Malfunction
Date Received
July 15, 2003
Date of Event
July 15, 2003
Report Date
July 15, 2003
Manufacturer
*
Product Code
LZG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

SEVERAL DATES. INFECTIONS SEVERAL TIMES IN A ROW AT INFUSION SITES IN THE MOST SANITARY CIRCUMSTANCES. CONSUMER USES RUBBING ALCOHOL TO CLEAN THEIR HANDS AND CONSUMER NEW SITE. ALSO, NEEDLES ARE PAINFUL IF THEY ARE SHIPPED STUCK INTO THE PLASTIC TUBING THAT IS SUPPOSED TO PROTECT IT. ALSO HAVING PROBLMES WITH SHIPPING ORDERS THAT "SLIPPED THROUGH THE CRACKS", AND "SOMETHING HAPPENED TO THE ORDER" AND THEIR SUPPLIES NOT BEING SHIPPED. CONSUMER HAS TO DO THE JOB OF BABYSITTING THEM AND CALLING TO MAKE SURE THEY SHIP THEIR ORDERS. REPLACEMENT PRODUCT DOES NOT GET SHIPPED AND IT FINALLY DOES AFTER CONSUMER CALLS AND COMPLAIN. THEY SHIP INFUSION SETS THAT NEVER EVEN HAD THE NEEDLE GUARDS PUT ON IN THE FACTORY. THEY ARE LOOSE IN THE PACKAGING, BUT THEY CANNOT SHAKE THEM INTO THE AREA OF THE PACKAGING THE CONTAINS THE NEEDLE. THEY CLAIM THAT "THE OLDER PTS CANNOT SEE THE TUBING SO THEY DON'T EVEN BOTHER TO PUT THE TUBING OVER THE NEEDLE, BUT IT GOES IN THE PACKAGE SO THAT THE OTHER PTS CAN PUT IT OVER THE NEEDLES". THEY CANNOT GET THE NEEDLE INTO THE INSERTION DEVICE WITHOUT THE GUARD; THEY CANNOT REMOVE THE PAPERS FROM THE ADHESIVE WITHOUT THE GUARD, AND THE NEEDLE RUBS AND BOUNCES AGAINST THE PACKAGING IF THERE IS NO GUARD ON IT! THESE INFECTIONS CONSUMER KEEPS GETTING REQUIRE STRONG ANTIBIOTICS AND THE INFECTION IS DANGEROUS BECAUSE IT GETS INTO THE BLOODSTREEM. CONSUMER INSPECTS RECEIPT AND CALLS AND ARRANGES RETURN OF ALL INFUSION SETS THAT SHIPS WITHOUT THE TUBING PROTECTING THE NEEDLE, OR THE ONES WITH NEEDLES STUCK IN THE TUBING BECAUSE IT DAMAGES THE NEEDLE AND MAKES FOR PAINFUL INSERTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC-MINIMED INSULIN PUMP INFUSION SETS LZG * 508 *

Patients

Seq Age Sex Outcome Treatment
1 38 YR Other