FDA Adverse Event Malfunction Summary report: N

AUTOSOFT XC

MDR report key: 19947111 · Received August 9, 2024

Report

Report Number: 3003442380-2024-20186
Event Type: Malfunction
Date Received: August 9, 2024
Date of Event: May 1, 2024
Report Date: July 10, 2024
Manufacturer: UNOMEDICAL A/S
Product Code: FPA
UDI-DI: 05705244026032
PMA / PMN Number: K032854
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

INITIAL AND FINAL MDR 1935288 - MDR (B)(4). H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

Description of Event or Problem · 0

REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED KINKED CANNULA EVENT ON 01-MAY-2024. THE EVENT OCCURRED AFTER THREE HOURS OF INSERTION. THE INFUSION SET WAS INSERTED IN ABDOMEN. BLOOD GLUCOSE LEVELS DURING THE EVENT WERE 300 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY DO NOT SEE 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 WAS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1634993	AUTOSOFT XC	INSET I 2-PACK 60/9 GREY TCAP	FPA	UNOMEDICAL A/S	1010899	UNKNOWN	05705244026032

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR	Female