FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4150001 · Received October 7, 2014

Report

Report Number: 2032227-2014-34895
Event Type: Injury
Date Received: October 7, 2014
Date of Event: September 8, 2014
Report Date: September 8, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Additional Manufacturer Narrative · 1

INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM FUNCTIONAL TESTS INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS DUE TO MOTOR ERROR ALARM. INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT SHE WAS BEING DISCHARGED FROM THE HOSPITAL FOR HER BACK SURGERY AND RECEIVED A MOTOR ERROR ALARM DURING BASAL. CUSTOMER ALSO REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE READINGS OF 360 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. NO FURTHER INFORMATION REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
626809	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723LNAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Hospitalization