FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4103500 · Received September 19, 2014

Report

Report Number: 2032227-2014-26486
Event Type: Malfunction
Date Received: September 19, 2014
Date of Event: June 17, 2014
Report Date: August 21, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH FAILED BATTERY ALARM DUE TO CORRODED BATTERY TUBE. THE UNIT RECEIVED WITH BATTERY CAP DAMAGE DUE TO STRIPPED COIN SLOT, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, AND CRACKED RESERVOIR TUBE LIP.

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

CUSTOMER REPORTED NOT USING THE INSULIN PUMP FOR THE PAST MONTH DUE TO A BATTERY ISSUE. CUSTOMER STATED THAT SHE HAS BEEN RECEIVING FAILED BATTERY TESTS EVEN WHEN NEW BATTERIES ARE INSTALLED IN THE INSULIN PUMP. BLOOD GLUCOSE LEVEL WAS 536 MG/DL AT THE TIME OF THE CALL. DURING A FOLLOW UP CALL, THE CUSTOMER REPORTED BEING UNABLE TO REMOVE THE INSULIN PUMP'S BATTERY CAP. BLOOD GLUCOSE LEVEL WAS 160 MG/DL AT THE TIME OF THIS CALL. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
584496	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-723LNAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR