PARADIGM REAL-TIME INSULIN INFUSION PUMP

Report

Report Number: 3004209178-2013-91244
Event Type: Injury
Date Received: February 21, 2013
Date of Event: February 9, 2013
Report Date: February 9, 2013
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A FAULTY SENSOR. HOWEVER, THE REWIND AND DISPLACEMENT TEST PASSED. UNABLE TO CONFIRM MOTOR ERROR ALARMS. THE MOTOR PASSED THE MOTOR TEST. THE UNIT METER FEATURE WAS FUNCTIONING PROPERLY. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER WAS IN THE INTENSIVE CARE UNIT DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 500MG/DL. IT WAS STATED THAT THE CUSTOMER EXPERIENCED HEADACHES, NAUSEA, AND VOMITING. IT WAS STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT TIME OF ADMISSION, BUT THEY REMOVE THE DEVICE AND TREATED HIS BLOOD GLUCOSE WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP IS FLUSH. REVIEWED THE ALARM HISTORY AND FOUND MOTOR ERROR ALARMS. ASSISTED THE CUSTOMER TO PERFORM THE DISPLACEMENT AND SELF TEST AND THEY PASSED. ADVISED THE NURSE THAT THE INSULIN PUMP WOULD BE REPLACED AND THE CUSTOMER SHOULD REVERT TO BACK UP PLAN. THE CUSTOMER ALSO MENTIONED THAT HIS BLOOD GLUCOSE READING ON THE ULTRALINK WAS DIFFERENT FROM THE BLOOD GLUCOSE READING TAKEN AT THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
75585	PARADIGM REAL-TIME INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-722NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	21 YR		Hospitalization