FDA Adverse Event Malfunction Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 3812423 · Received April 15, 2014

Report

Report Number: 3004464228-2014-00483
Event Type: Malfunction
Date Received: April 15, 2014
Date of Event: March 18, 2014
Report Date: March 18, 2014
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K122953
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED DAMAGED CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD'S USER GUIDE WARNS TO "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

Description of Event or Problem · 1

THE CUSTOMER REPORTED ON (B)(6) 2014 AT 8:05 AM SHE ACTIVATED A NEW POD AND HER BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY IS AS FOLLOWS: TIME: 8:44 AM, BG (MG/DL): 181, CHO (G): 10, BOLUS (U): 2.1. TIME: 12:16 PM, BG (MG/DL): 485, BOLUS (U): 1.55. TIME: 1:06 PM, BG (MG/DL): 484 (ALTERNATIVE METER). TIME: 1:35 PM, BOLUS (U): 3.0. TIME: 3:51 PM, BG (MG/DL): 467 (ALTERNATIVE METER). AT 4:21 PM, THE POD WAS DEACTIVATED. SHE NOTICED THE CANNULA APPEARS TO BE SHORTER AND IT LOOKS LIKE THE CANNULA WAS SHAVED OFF. AT 4:26 PM, SHE WAS ABLE TO ACTIVATE NEW POD AND GAVE A BOLUS OF 3.5 UNITS OF INSULIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
230772	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	14000	L40809

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR