FDA Adverse Event Malfunction Summary report: N

AUTOSOFT 90

MDR report key: 20015259 · Received August 21, 2024

Report

Report Number: 3003442380-2024-21327
Event Type: Malfunction
Date Received: August 21, 2024
Date of Event: June 13, 2024
Report Date: July 19, 2024
Manufacturer: UNOMEDICAL A/S
Product Code: FPA
UDI-DI: 05705244018129
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 1944505- MDR 3003442380-2024-21327 - DEVICE 4 OF 7. 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 CANADA. IT WAS REPORTED THAT, THE PATIENT FACED ISSUE OF 7 INFUSION SETS CANNULA BEING KINKED ON 13-JUN-2024. THE BLOOD GLUCOSE LEVEL WAS 28 MMOL/L WHICH WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION. THE EVENT OCCURED 3 OR MORE HOURS AFTER INSERTION, AFTER BEING IN USE FOR 7-8 HOURS. THE SITE OF INSERTION WAS LOCATED AT ABDOMEN AND THIGH. THE ISSUE WAS RESOLVED BY REPLACING INFUSION SET AND RESUMING INSULIN. COMPANY 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
2286076	AUTOSOFT 90	UNO INSET II 60/6 GREY TCAP 10PK INT	FPA	UNOMEDICAL A/S	1002817	UNKNOWN	05705244018129

Patients

Seq	Age	Sex	Outcome	Treatment
1	10 YR	Unknown