FDA Adverse Event Injury Summary report: N

AUTOSOFT XC

MDR report key: 16773922 · Received April 19, 2023

Report

Report Number
3003442380-2023-00241
Event Type
Injury
Date Received
April 19, 2023
Report Date
April 20, 2023
Product Code
FPA
UDI-DI
05705244016620
PMA / PMN Number
K032854
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

UNOMEDICAL REFERENCE NUMBER 1652091. EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULAS DUE TO WHICH SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THEREFORE, THEY TRIED TO TREAT IT WITH BOLUS VIA THE PUMP AND CHANGED THE INFUSION SET, BUT ON (B)(6)-2023, THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL. HER HIGHEST BLOOD GLUCOSE LEVEL WAS AROUND 686 MG/DL, AND THE PATIENT INFORMED THE HOSPITAL STAFF THAT SHE WAS IN ACTIVE DIABETIC KETOACIDOSIS. MOREOVER, THE INFUSION SET HAD BEEN USED FOR AROUND FOUR HOURS AND THE SITE LOCATION WAS PATIENT'S ABDOMEN. FURTHER, ON (B)(6) 2023, THE PATIENT AGAIN FACED A BENT CANNULA WHICH WAS NOTICED AFTER THREE HOURS OF INSERTION. DURING HOSPITALIZATION, THE PATIENT RECEIVED UNKNOWN FLUIDS INTRAVENOUSLY AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. ON (B)(6) 2023, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. ON THE DAY OF RELEASE, THE PATIENT FACED A BENT CANNULA AGAIN WITH PATIENT'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 100-125 MG/DL. THE SITE LOCATION WAS PATIENT'S ARM FOR THIS EVENT.  UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1157362 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA 1001680 5408225 05705244016620

Patients

Seq Age Sex Outcome Treatment
1 Unknown