PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

Report

Report Number: 2032227-2013-00906
Event Type: Injury
Date Received: March 6, 2013
Date of Event: February 19, 2013
Report Date: February 19, 2013
Manufacturer: MEDTRONIC MINIMED
Product Code: OYC
PMA / PMN Number: P980022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OR
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

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

THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED WITH A BLOOD GLUCOSE OF 566 MG/DL. THE CUSTOMER WAS GIVEN AN INSULIN INJECTION, BUT CONTINUED TO EXPERIENCE HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION BECAUSE IT HADN'T BEEN WORKING. THE CUSTOMER HAD BEEN GETTING NO DELIVERY ALARMS PRIOR TO THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. ADVISED THE CUSTOMER OF A POSSIBLE SITE ISSUE. ADVISED THE CUSTOMER TO TRY USING DIFFERENT AREAS OF THE BODY TO AVOID INSERTING INTO SCAR TISSUE. THE CUSTOMER AND HER HUSBAND BOTH FELT THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY, AND REQUESTED A REPLACEMENT. NOTHING FURTHER WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
95058	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC MINIMED	MMT-523LNAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Hospitalization