FDA Adverse Event Injury Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 1911739 · Received November 24, 2010

Report

Report Number: 2531779-2010-02536
Event Type: Injury
Date Received: November 24, 2010
Date of Event: October 11, 2010
Report Date: October 26, 2010
Manufacturer: ANIMAS CORP.
Product Code: LZG
PMA / PMN Number: K042873
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE LIKELY CAUSE OF THE ELEVATED BLOOD GLUCOSE WAS USE ERROR; THE PT DID NOT HAVE THE TIME OR DATE CORRECTLY PROGRAMMED AND HE DID NOT AWAKE TO THE AUTO-OFF ALARM. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

Description of Event or Problem · 1

THE PT REPORTED THAT HE AWOKE ON THE MORNING OF (B)(6) 2010 WITH A VERY HIGH BLOOD GLUCOSE READING OF UNK VALUE. HE SAID THAT THE PUMP HAD THE MESSAGE "NOT PRIMED, NO DELIVERY" ON THE SCREEN. THE PT REPORTED THAT HE WAS ADMITTED TO HOSPITAL WITH A DIAGNOSIS OF DKA. HE SPENT TWO DAYS IN THE HOSPITAL AND THEN WAS RELEASED TO HOME ON THE PUMP. THE PT REVIEWED THE ALARM HISTORY AND RECORD #1 WAS AN AUTO-OFF ALARM WITH THE DATE OF (B)(6) 2011. THE PT CONFIRMED THAT THE DATE IN THE PUMP WAS SET TO (B)(6) 2011 AND THE TIME WAS INCORRECT BY 12 HOURS. THE ALARM WAS SET TO GO OFF AFTER 10 HOURS OF NO BUTTON PRESSES. FURTHER REVIEW OF THE PUMP HISTORY CONFIRMED THAT THE PT RECEIVED AN AUTO-OFF ALARM DURING THE NIGHT PRECEDING THE HOSPITALIZATION. THE PT ACKNOWLEDGED THAT HE SLEPT THROUGH THE ALARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANIMAS INSULIN INFUSION PUMP	INSULIN INFUSION PUMP	LZG	ANIMAS CORP.	ANIMAS 2020	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Hospitalization