FDA Adverse Event Injury Summary report: N

ONETOUCHPING GLUCOSEMGMTSYSTEM

MDR report key: 2770249 · Received October 3, 2012

Report

Report Number: 2531779-2012-11694
Event Type: Injury
Date Received: October 3, 2012
Report Date: September 7, 2012
Manufacturer: ANIMAS CORPORATION
Product Code: LZG
PMA / PMN Number: 080639
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

Description of Event or Problem · 1

ON (B)(6) 2012 THE REPORTER, THE PATIENT'S MOTHER, REPORTED THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED THE SYMPTOMS OF NAUSEA, VOMITING AND ABDOMINAL CRAMPS, AND WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DKA. THIS EVENT OCCURRED ONE WEEK AFTER THE PATIENT STARTED INSULIN PUMP THERAPY. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE PATIENT/REPORTER MULTIPLE TIMES TO OBTAIN INFORMATION AND TO TROUBLESHOOT THE PUMP; HOWEVER, WAS UNABLE TO REACH HER BY TELEPHONE. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CIRCUMSTANCES AND STATUS PRIOR TO THE ONSET OF SYMPTOMS, NOR ABOUT THE PUMP'S SETTINGS OR USE. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF SEVERE HYPERGLYCEMIA WHILE USING THE PUMP, AND WAS ADMITTED TO THE HOSPITAL IN DKA. THEREFORE THIS COMPLAINT IS BEING REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ONETOUCHPING GLUCOSEMGMTSYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORPORATION	OTP GLUCOSE MGMT SYSTEM

Patients

Seq	Age	Sex	Outcome	Treatment
1	7 YR		Hospitalization\| L