FDA Adverse Event Malfunction Summary report: N

ASANTE CONSET

MDR report key: 5292443 · Received October 24, 2014

Report

Report Number: 3003442380-2014-00094
Event Type: Malfunction
Date Received: October 24, 2014
Date of Event: August 6, 2014
Report Date: October 23, 2014
Manufacturer: UNOMEDICAL DEVICE S.A.
Product Code: FPA
PMA / PMN Number: K120872
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS MDR REPORT HAS BEEN MADE SINCE A SIMILAR EVENT HAS LED TO A RECALL. THIS EVENT WAS WRONGLY NOT REPORTED TO THE FDA THEREFORE THIS IS A FOLLOW-UP. IN NOVEMBER 2013 A VOLUNTARY PRODUCT RECALL FOR THE DEVICE WAS INITIATED AND REPORTED TO THE FDA UNDER REPORT# 8021545-11/19/2013-0006. ACCORDING TO THE EVALUATION RESULT, PLEASE SEE ATTACHMENT 2 WHICH IS AN EXTRACT OF THE INFORMATION SENT TO THE FDA IN RELATION TO THE RECALL. (UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH ASANTE SOLUTIONS, THE DISTRIBUTOR OF THE INFUSION SET. THE INTERNAL REFERENCE NUMBER FOR THIS COMPLAINT AT ASANTE SOLUTION IS (B)(4)).

Description of Event or Problem · 1

ASANTE REPRESENTATIVE REPORTED THAT A PATIENT CALLED TO REPORT A TUBING DETACHED FROM TUBING CONNECTOR OVERNIGHT AT 2AM WITH HIGH BG. ATTACHED IS THE LOT NUMBER OF SETS. PATIENT IS ON THE TRIAL PROGRAM AND PLEASE NOTE, THIS IS THE SECOND ISSUE SHE HAS HAD WITH PRODUCT IN THE FIRST WEEK OF STARTING TRIAL. IN FOLLOW-UP CALL TO PATIENT, SHE STATED THAT THIS OCCURRED WITH ONLY ONE INFUSION SET SO FAR. HER BG RETURNED TO NORMAL ONCE SHE CHANGED THE INFUSION SET AND SHE STARTED RECEIVING HER INSULIN DOSAGE. ASANTE INFORMED HER THAT THEY WOULD BE SENDING HER REPLACEMENT INFUSION SET AND A BOX TO RETURN THE TUBING THAT BECAME DETACHED FROM THE TUBING CONNECTOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
680869	ASANTE CONSET	ASANTE CONSET	FPA	UNOMEDICAL DEVICE S.A.	PIDS FG# 4229-5	5062707

Patients

Seq	Age	Sex	Outcome	Treatment
1