DISETRONIC TENDER
Received May 22, 2001 · Event occurred Jan 30, 2001
Report 8021545-2001-00023 · MDR key 334549
Device
Generic name
Subcutaneous Infusion Set
Manufacturer
Maersk Medical A/sModel number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Complaint, Ill-Defined
Narrative
Description of Event or Problem
IN 2001 THE END-USER HAD CHANGED THE INFUSION SET. NEXT MORNING ENDUSER WOKE UP AND END USER'S BLOOD SUGAR LEVEL WAS 32.0. END USER HAD BOULSSED SOME EXTRA INSULIN (16 UNITS). AFTER THIS END USER'S BLOOD SUGAR LEVEL WAS 34.0. END USER BOLUSSED SOME MORE INSULIN AND END USER'S BLOOD SUGAR LEVEL BECAME 37.0. END USER CONTACTED END USER'S HOSPITAL BY PHONE. THEY GAVE END USER THE ADVISE TO TAKE END USER'S SPARE PUMP (WHAT END USER DID). END USER BOLUSSED SOME EXTRA INSULIN WITH END USER'S INSULIN PEN (IN END USER'S ARM) BY 7:00 PM ENDUSER'S BLOOD SUGAR LEVEL WAS 10.3. ON APRIL 9, 2001 MAERSK MEDICAL RECEIVED THE COMPLAINT AND 1 USED INFUSION SET.
Remedial action
- Replace