FDA Adverse Event Injury Summary report: N

OMNIPOD INSULIN PUMP

MDR report key: 3170135 · Received June 6, 2013

Report

Report Number: 3004464228-2013-00565
Event Type: Injury
Date Received: June 6, 2013
Date of Event: April 27, 2013
Report Date: May 7, 2013
Manufacturer: INSULET CORPORATION
Product Code: LZG
PMA / PMN Number: K042792
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED INACCURATE LOW MEASUREMENT OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE PT'S HOSPITALIZATION. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "IF YOU ARE EXPERIENCING SYMPTOMS THAT ARE NOT CONSISTENT WITH YOUR BLOOD GLUCOSE READING AND YOU HAVE FOLLOWED ALL INSTRUCTIONS DESCRIBED IN THIS USER GUIDE, CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY" AND ADVISES "YOU SHOULD PERFORM A CONTROL SOLUTION TEST WHEN YOU SUSPECT THAT YOUR METER OR TEST STRIPS ARE NOT WORKING PROPERLY, WHEN YOU THINK YOUR TEST RESULTS ARE NOT ACCURATE, OR IF YOUR TEST RESULTS ARE NOT CONSISTENT WITH HOW YOU FEEL."

Description of Event or Problem · 1

THE PT REPORTED THAT SHE WAS FIVE HOURS AWAY FROM HOME AT HER GRANDPARENTS' HOUSE WHEN SHE FELT SICK. BY THE TIME SHE GOT HOME AND WAS TAKEN TO THE HOSPITAL, HER VENOUS BLOOD GLUCOSE RESULTS WAS 475 MG/DL. HER PDM WAS READING 250 MG/DL. SHE STATED THAT WHEN SHE STARTED USING HER BACKUP PDM WITH THE SAME POD LOT AND VIAL OF TEST STRIPS, SHE GOT CORRECT READINGS. NO INFORMATION WAS PROVIDED AS HER TREATMENT OR LENGTH OF STAY IN THE HOSPITAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
251972	OMNIPOD INSULIN PUMP	PUMP, INFUSION, INFUSLIN	LZG	INSULET CORPORATION	13100-2B	L50070

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR		Hospitalization