OMNIPOD INSULIN PUMP

MDR report key: 8560139 · Received April 29, 2019

Report

Report Number: 3004464228-2019-03593
Event Type: Malfunction
Date Received: April 29, 2019
Date of Event: February 14, 2019
Report Date: February 15, 2019
Manufacturer: INSULET CORPORATION
Product Code: LZG
UDI-DI: 20385081120033
PMA / PMN Number: K162296
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PMA/510(K) # CHANGED FROM K122953 TO K162296. CATALOG NO CHANGED FROM ZXY425 TO ZXP425.

Additional Manufacturer Narrative · 1

THE RETURNED DEVICE WAS EVALUATED AND THE INVESTIGATION FOUND A HOLE IN THE EXPOSED PORTION OF THE SOFT CANNULA. WHEN THE DISTAL TIP WAS MANUALLY OCCLUDED, FLUID DIVERTED THROUGH THE HOLE. ALTHOUGH THE CANNULA WAS DAMAGED, THE TIMING AND CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: ENT450; 17845-5C-AW REV A 10/17. CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36: WARNINGS: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNINGS: IF YOU GET RESULTS BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 117), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE REACHED 380 MG/DL AFTER WEARING THE POD BETWEEN 36 AND 48 HOURS ON THE HIP/BUTTOCKS. HYPERGLYCEMIA TREATED BY PATIENT ACTIVATING A NEW POD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
353310	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	19191	L44061	20385081120033

Patients

Seq	Age	Sex	Outcome	Treatment
1