FDA Adverse Event Malfunction Summary report: N

CE INTERMATE LV 250, 24 PACK,50126

MDR report key: 1790804 · Received August 10, 2010

Report

Report Number: 6000001-2010-02451
Event Type: Malfunction
Date Received: August 10, 2010
Date of Event: July 20, 2010
Report Date: July 20, 2010
Manufacturer: BAXTER HEALTHCARE - IRVINE
Product Code: MEB
PMA / PMN Number: K910425
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE EVALUATION OF THE RESERVOIR RUPTURED HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED AND EVALUATED BY BAXTER. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. A BATCH REVIEW HAS BEEN PERFORMED. ALL RELEASE CRITER WERE MET FOR THE PRODUCTION OF THIS BATCH.THERE IS A CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION ASSOCIATED WITH THIS REPORT, (B)(4).

Description of Event or Problem · 1

IT WAS STATED THAT THE CUSTOMER PASSED AWAY DUE TO DIABETES COMPLICATIONS. THE WIFE STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE WIFE DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

Description of Event or Problem · 1

A SAMPLE WAS RETURNED FOR EVALUATION FOR THE REPORTED CONDITION OF BROKEN STEM; HOWEVER, A RUPTURED RESERVOIR WAS OBSERVED DURING BAXTER DEVICE EVALUATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CE INTERMATE LV 250, 24 PACK,50126	PUMP, INFUSION	MEB	BAXTER HEALTHCARE - IRVINE		09M031

Patients

Seq	Age	Sex	Outcome	Treatment
1