FDA Adverse Event Injury Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 6083725 · Received November 7, 2016

Report

Report Number: 2032227-2016-40182
Event Type: Injury
Date Received: November 7, 2016
Date of Event: October 15, 2016
Report Date: October 15, 2016
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY. THE CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 477 MG/DL AT THE TIME OF CALL. THE CUSTOMER'S BLOOD GLUCOSE WAS 517 MG/DL AT THE END OF CALL. THE CUSTOMER STATED THAT THEY TREATED THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER PERFORMED TROUBLESHOOTING AND FOUND THAT THE CANNULA WAS BENT. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR, INSULIN AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
735356	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-723LNAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Other