FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 10413617 · Received August 17, 2020

Report

Report Number: 3004464228-2020-13021
Event Type: Malfunction
Date Received: August 17, 2020
Date of Event: August 13, 2020
Report Date: August 13, 2020
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K162296
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

PER NEW INFORMATION THE FOLLOWING WERE UPDATED: D4: MODEL NO CHANGED FROM 14810 TO 19191. D4: LOT NO CHANGED FROM BLANK TO L45694. D4: CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4: EXPIRATION DATE CHANGED FROM BLANK TO 10/9/2021. D4: UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). G5: PMA/510(K) # CHANGED FROM K192659 TO K162296. H4: DEVICE MFG DATE CHANGED FROM BLANK TO 4/9/2020.

Additional Manufacturer Narrative · 0

THE POD WAS RECEIVED NOT DEPLOYED. NO ISSUES WERE FOUND THAT WOULD RESULT IN A NEEDLE MECHANISM FAILURE AS THE POD WAS DEACTIVATED AFTER THE FIRST PRIMING SEQUENCE ENDED AND BEFORE THE START OF THE SECOND PRIMING SEQUENCE.

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

Description of Event or Problem · 1

IT WAS REPORTED THE NEEDLE DID NOT DEPLOY, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
881053	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	19191	L45694

Patients

Seq	Age	Sex	Outcome	Treatment
1