FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 9179262 · Received October 11, 2019

Report

Report Number: 3004464228-2019-10100
Event Type: Malfunction
Date Received: October 11, 2019
Date of Event: September 12, 2019
Report Date: September 22, 2019
Manufacturer: INSULET CORPORATION
Product Code: LZG
UDI-DI: 20385081120002
PMA / PMN Number: K162296
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

CORRECTION TO MODEL NO CHANGED FROM 14000 TO 19191. UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO(B)(4). CORRECTION TO THE PMA/510(K) # CHANGED FROM K122953 TO K162296.

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400, 17845-5A-AW REV B 09/17. CHANGING YOUR POD: CHAPTER 3 / PAGES 33; WARNING: CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT.

Additional Manufacturer Narrative · 1

THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED AND THE NEEDLE COMPLETELY RETRACTED. NO ISSUES WERE OBSERVED THAT WOULD RESULT IN A LATE NEEDLE DEPLOYMENT OR A FAILURE TO DELIVER INSULIN. THE REPORTED EVENT COULD NOT BE DETERMINED.

Description of Event or Problem · 1

THE PATIENT REPORTED THAT THE NEEDLE DEPLOYED THE CANNULA LATE. THE POD WAS NOT WORN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
976352	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	19191	L44517	20385081120002

Patients

Seq	Age	Sex	Outcome	Treatment
1