FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4110521 · Received September 23, 2014

Report

Report Number: 2032227-2014-27381
Event Type: Malfunction
Date Received: September 23, 2014
Date of Event: August 25, 2014
Report Date: August 25, 2014
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

INSULIN PUMP RECEIVED WITH CONSTANT MOTOR ERROR ALARMS DURING REWIND DUE TO ENCODER SIGNAL OUT OF PHASE. INSULIN PUMP WAS UNABLE TO PERFORM DISPLACEMENT TEST, BASIC OCCLUSION TEST, PRIME TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MISSING END CAP STICKER.

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. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 84 MG/DL. TROUBLESHOOTING WAS DONE. CUSTOMER STATED UNABLE TO REWIND THE INSULIN PUMP. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
592023	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-723NAB

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR