ONE TOUCH LANCING DEVICE
Report
- Report Number
- 2939301-2014-18993
- Event Type
- Injury
- Date Received
- July 29, 2014
- Report Date
- July 21, 2014
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PATIENT
Narratives
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.
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE LANCET FROM HER ONE TOUCH LANCING DEVICE (MINI LANCER) DOES NOT FULLY PENETRATE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT DOES NOT RECALL WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE AND DOSAGE) AND STATED SHE TOOK A DECREASED DOSE OF INSULIN (UNKNOWN TYPE AND DOSAGE) IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT STATED, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿SWEATY AND SHAKY¿. THERE WAS NO MENTION OF RECEIVING MEDICAL TREATMENT FOR A HIGH OR LOW BLOOD GLUCOSE EXCURSION. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THIS WAS NOT THE FIRST TIME THE PATIENT USED THE LANCING DEVICE, AND THERE WAS NO MISUSE OF THE PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED LANCING DEVICE ISSUE BEGAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441445 | ONE TOUCH LANCING DEVICE | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |