FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 6365467 · Received February 28, 2017

Report

Report Number: 2032227-2017-07904
Event Type: Malfunction
Date Received: February 28, 2017
Date of Event: July 13, 2013
Report Date: July 13, 2013
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SD
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

UNIT RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO TRACES OF MOISTURE WERE NOTED AT ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. UNIT PASSED THE SELF TEST, A21 ERROR TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED A21 ERROR ALARMS WERE NOTED. UNIT RECEIVED WITH CRACKED CASE AT KCD WINDOW CORNERS, RESERVOIR TUBE AND BATTERY TUBE THREADS. UNIT RECEIVED WITH SCRATCHED LCD WINDOW. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA.

Description of Event or Problem · 1

THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM AND BUTTON ERROR ALARM. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 55 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
146352	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-523LNAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR