FDA Adverse Event Malfunction Summary report: N

RESERVOIR 3ML

MDR report key: 3900950 · Received June 27, 2014

Report

Report Number: 3004209178-2014-86313
Event Type: Malfunction
Date Received: June 27, 2014
Date of Event: June 10, 2014
Report Date: June 11, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: FRN
PMA / PMN Number: K032005
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Additional Manufacturer Narrative · 1

INSPECTED ONE OPEN AND USED RESERVOIR. RESERVOIR PASSED TEST ACCORDING TO SPECIFICATIONS. NO AIR BUBBLES WERE OBSERVED DURING ANALYSIS. CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WERE FOUND. INSPECTED SNAP-CAP AND FOUND THAT IT WAS TOO LOOSE TO CONNECT/RELEASE PROPERLY.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR THE DAY BEFORE AND AFTER TWO HOURS HER BLOOD GLUCOSE LEVEL ROSE UP TO 20MMOL/L. THE CUSTOMER CHECKED THE TUBING AND NOTED AIR BUBBLES IN THE LINE. THEN SHE DISCONNECTED AND GOT READY OF THE AIR BUBBLES. THE CALLER NOTICED THAT THE P-CAP CONNECTION AT THE RESERVOIR WAS LOOSE AND THE CUSTOMER BELIEVES THIS WAS THE CAUSE FOR THE AIR BUBBLES. THE CUSTOMER MENTIONED ALSO HAVING A BENT CANNULA AND AS KETONES WERE RISING SHE GAVE HER A MANUAL INJECTION. THE CUSTOMER STATED CALLING TO THE HOSPITAL SEVERAL TIMES TO GET ASSISTANCE WITH HER BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
377139	RESERVOIR 3ML	RESERVOIR	FRN	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-332A	HG020YU

Patients

Seq	Age	Sex	Outcome	Treatment
1