FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 3990377 · Received August 7, 2014

Report

Report Number: 3004209178-2014-91175
Event Type: Malfunction
Date Received: August 7, 2014
Date of Event: July 8, 2014
Report Date: July 8, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI
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. 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 RECEIVED WITH MISSING SEGMENTS AND STRAIGHT LINE, PROBLEM ISOLATED TO LCD BOARD. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULIN PUMP HAD A LINE ON ITS DISPLAY AND THAT THE DISPLAY DID NOT RETURN TO NORMAL AFTER A BATTERY REPLACEMENT. THE BLOOD GLUCOSE READING WAS 185 MG/DL. THE CUSTOMER STATED THAT THE DEVICE HAD NEITHER BEEN DROPPED NOR BUMPED. SHE ALSO OBSERVED THAT A FEW DAYS PRIOR, WHEN IT WAS QUITE HOT, THERE WAS A STRAIGHT LINE ON THE DISPLAY, BUT WHEN THE DEVICE WAS ON SUSPEND, THE LINE WENT AWAY. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
464511	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR