FDA Adverse Event Injury Summary report: N

ONE TOUCH LANCING DEVICE

MDR report key: 2030042 · Received March 25, 2011

Report

Report Number: 2939301-2011-02643
Event Type: Injury
Date Received: March 25, 2011
Date of Event: March 22, 2011
Report Date: March 25, 2011
Manufacturer: LIFESCAN INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP # 1 (05/23/2011)-DEVICE EVALUATION: THE LANCING DEVICE INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011. THE RETURNED LANCING DEVICE FAILED TESTING: A BROKEN LANCET HOLDER ISSUE WAS CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

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.

Description of Event or Problem · 1

THE PATIENT'S WIFE CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE IN (B)(4) ON (B)(6) 2011 ALLEGING A LANCING DEVICE ISSUE WITH HER HUSBAND'S ONETOUCH LANCING DEVICE. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE REPORTED ISSUE WAS NOT RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED LOW BLOOD GLUCOSE SYMPTOMS (SHAKY, WEAKNESS, AND RAPID HEARTBEAT) BECAUSE HE WAS UNABLE TO TEST WITH THE LANCING DEVICE FOR ABOUT 2-3 DAYS. ACCORDING TO THE PATIENT'S WIFE, THE PATIENT DID NOT RECEIVE ANY TREATMENT. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ONE TOUCH LANCING DEVICE	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Life Threatening