FDA Adverse Event Malfunction Summary report: N

AUTOSOFT 90

MDR report key: 19999171 · Received August 18, 2024

Report

Report Number: 3003442380-2024-21167
Event Type: Malfunction
Date Received: August 18, 2024
Date of Event: June 17, 2024
Report Date: July 16, 2024
Manufacturer: UNOMEDICAL A/S
Product Code: FPA
UDI-DI: 05705244018303
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 1940996 - MDR 3003442380-2024-21167 - DEVICE 3 OF 6. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. 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. ON 17-JUNE-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED SIX INFUSION SETS CANNULA KINKED EVENTS WITHIN 3 HOURS OF INSERTION. THE SITE OF INSERTION WAS SOME WERE ON ABDOMEN AND SOME ON OUTER THIGH AREA, FOR ALL SETS. THE BLOOD GLUCOSE WAS REPORTED HIGH AND TREATED WITH BOLUS VIA PUMP. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1153059	AUTOSOFT 90	UNO INSET II 60/6 BLUE TCAP 10PK INT	FPA	UNOMEDICAL A/S	1002823	UNKNOWN	05705244018303

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR	Female