FDA Adverse Event Injury Summary report: N

TECHLITE LANCETS

MDR report key: 1170147 · Received September 20, 2008

Report

Report Number
MW5008371
Event Type
Injury
Date Received
September 20, 2008
Date of Event
September 18, 2008
Report Date
September 20, 2008
Manufacturer
ARKRAY USA, INC.
Product Code
FMK
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

DEAR MR. PLEASE BE ADVISED THAT I HAVE DIABETES AND TAKE INSULIN. I NEED TO MONITOR MY BLOOD SUGAR OFTEN -BEFORE INJECTION INSULIN- DURING THE DAY. IT HAS COME TO MY ATTENTION THAT THE PHARMACY- WILL ALLOW ONLY 200-SINGLE USE LANCETS -TECHLITE LANCETS- TO BE PRESCRIBED PER PT FOR A 1-YEAR -200 - LANCETS FOR 365 DAYS PERIOD. I HAVE BEEN TOLD TO REUSE THE LANCETS BY THE PHARMACY THROUGH THE MEDICAL STAFF. I WISH TO KNOW IF YOU KNOW ABOUT THIS POLICY AND/OR I WISH TO KNOW THE NAME, ADDRESS AND TITTLE OF THE PERSON THAT GAVE THIS POLICY DIRECTIVE TO YOU AND/OR THE STAFF AND/OR THE PHARMACY? I ALSO REQUEST THAT YOU SEND ME A COPY OF THE FDA APPROVAL THAT ALLOWS THIS PRODUCT TO BE USED OVER AND OVER AGAIN AS I HAVE BEEN INSTRUCTED TO DO. AS TIME IS ALWAYS THE GREATEST OF IMPORTANCE, I WOULD HOPE TO HAVE YOUR REPLY IN MY POSSESSION WITHIN 14 DAYS. IF YOU HAVE ANY QUESTIONS PLEASE FEEL FREE TO CONTACT ME. ATTACHMENTS - 1 - MSDS - TECHLITE LANCETS ..... DATE: 9/19/2008, I WISH TO FILE A FORMAL COMPLAINT AGAINST THE HEALTHCARE SYSTEM. PLEASE SEE ATTACHED LETTER DATED 9/18/2008 - THAT WILL EXPLAIN MY COMPLAINT. I FIND IT INCOMPREHENSIBLE THAT THE FACILITY WOULD REQUIRE THE REUSE OF SINGLE USE LANCETS BY PATIENTS FOR THE MONITORING OF BLOOD SUGAR. BE ADVISED, PRIOR TO MY GOING FURTHER WITH THIS COMPLIANT, I WOULD HOPE TO HAVE YOUR REPLY IN MY POSSESSION WITHIN 14 - DAYS. IF YOU HAVE ANY QUESTIONS PLEASE FEEL FREE TO CONTACT ME. ATTACHMENTS - 2 - LETTERS MSDS - TECHLITE LANCETS. DOSE OR AMOUNT: SINGLE USE LANCET; FREQUENCY: SINGLE USE. DATES OF USE: 2008, CONTINUED USAGE. DIAGNOSIS OR REASON FOR USE: TEST BLOOD SUGAR. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TECHLITE LANCETS TECHLITE LANCETS FMK ARKRAY USA, INC. ARKRAY - TECHLITE 08L903B003

Patients

Seq Age Sex Outcome Treatment
1 61 YR Life Threatening