FDA Adverse Event Injury Summary report: N

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

MDR report key: 1944375 · Received December 21, 2010

Report

Report Number: 2531779-2010-03124
Event Type: Injury
Date Received: December 21, 2010
Date of Event: November 23, 2010
Report Date: November 27, 2010
Manufacturer: ANIMAS CORP.
Product Code: LZG
PMA / PMN Number: K080639
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE PUMP DELIVERY HISTORY MATCHED THE BASAL SETTING FOR THE DAY THE PT WAS HOSPITALIZED. THERE IS NO EVIDENCE THAT THE PUMP'S INSULIN DELIVERY WAS INACCURATE. THE PT DID NOT HAVE A BATTERY IN ORDER TO POWER THE PUMP AND NO FURTHER PUMP TROUBLESHOOTING WAS CONDUCTED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

Description of Event or Problem · 1

THE NURSE PRACTITIONER REPORTED THAT THE PT WAS IN A COMA DUE TO HYPOGLYCEMIA. SHE WANTED TO KNOW HOW TO CHECK THE PUMP FOR ANY DEFECTS. THE PT'S FAMILY MEMBERS REPORTED TO THE NURSE THAT SHE HAD SOME OTHER HYPOGLYCEMIC EVENTS LEADING UP TO THE COMA. THE PT WAS ADMITTED TO THE ICU OF THE HOSPITAL. WHEN SHE WAS TRANSPORTED BY THE EMT SHE WAS GIVEN DEXTROSE IV AND GLUCAGON EN ROUTE TO THE HOSPITAL. THE PT DOES NOT RECALL WHETHER SHE PRIMED THE PUMP WHILE THE INFUSION SET WAS ATTACHED TO HER BODY OR WHETHER SHE TOOK INJECTIONS VIA A SYRINGE. SHE DID NOT REMEMBER ANY CONTRIBUTING CAUSE FOR HER LOW BLOOD GLUCOSE LEVELS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM	INSULIN INFUSION PUMP	LZG	ANIMAS CORP.	ONE TOUCH PING	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR		Hospitalization\| L\| R