FDA Adverse Event Injury Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 4925668 · Received July 14, 2015

Report

Report Number: 3004464228-2015-00254
Event Type: Injury
Date Received: July 14, 2015
Date of Event: June 9, 2015
Report Date: June 17, 2015
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K122953
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA, HYPOGLYCEMIA AND ER VISIT. 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", AND "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

Description of Event or Problem · 1

THE PATIENT REPORTED THAT HER BLOOD GLUCOSE REACHED 465 MG/DL AFTER WEARING THE POD FOR 48 HOURS. SHE GAVE HERSELF A CORRECTIONAL BOLUS OF 2.5 UNITS OF INSULIN. SHE DECIDED TO GO TO THE EMERGENCY ROOM AND UPON ARRIVAL HER BG MEASURED 27 MG/DL SO THEY TREATED HER WITH AN INJECTION OF 30 (GRAMS) OF GLUCOSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
457933	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INSULIN	LZG	INSULET CORPORATION	14810	L41499

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization