FDA Adverse Event Malfunction Summary report: N

GLUCOSE MONITORING SYS/KIT

MDR report key: 1873304 · Received October 18, 2010

Report

Report Number: 2939301-2010-09174
Event Type: Malfunction
Date Received: October 18, 2010
Report Date: October 17, 2010
Manufacturer: LIFESCAN, INC.
Product Code: NBW
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT; 510(K)# IS K073231.

Additional Manufacturer Narrative · 1

(B)(4). THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

Description of Event or Problem · 1

THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN INFUSOR THAT HAD THE RESERVOIR RUPTURED DURING FILLING. THE DEVICE WAS BEING FILLED WITH SALINE. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

Description of Event or Problem · 1

THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER POWERS OFF DURING USE. IT WAS ALSO ALLEGED THE METER DOES NOT TURN ON WITH THE POWER BUTTON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN, INC.		3020670

Patients

Seq	Age	Sex	Outcome	Treatment
1