FDA Adverse Event Malfunction Summary report: N

ONETOUCH DELICA LANCETS

MDR report key: 19918745 · Received August 5, 2024

Report

Report Number
MW5158026
Event Type
Malfunction
Date Received
August 5, 2024
Report Date
August 5, 2024
Manufacturer
ASAHI POLYSLIDER COMPANY, LIMITED OKAYAMA-KUSE PLANT
Product Code
FMK
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

WE RECEIVED ORDERS FOR DIABETIC TESTING SUPPLIES FOR A PATIENT THAT DID NOT HAVE ANY SPECIFIC BRANDS PRESCRIBED, AS IS CUSTOMARY BECAUSE EACH INSURANCE HAS DIFFERENT CONTRACTS FOR DIFFERENT PREFERRED BRANDS. THIS PATIENT'S INSURANCE HAPPENS TO COVER ONE TOUCH VERIO, SO WE DISPENSED A ONE TOUCH VERIO METER, TEST STRIPS, AND THEN A GENERIC BRAND OF LANCETS, COMPATIBLE WITH MOST LANCING DEVICES. LATER, A NURSE CALLED THE PHARMACY WHILE GOING OVER HOW TO USE THE SUPPLIES WITH THE PATIENT, STATING THE LANCETS DIDN'T FIT INTO THE INCLUDED LANCING DEVICE. AS NEITHER THE NAME OF THE LANCING DEVICE, NOR THE NAME OF THE CORRESPONDING LANCETS ARE ON THE OUTSIDE OF THE PACKAGING FOR THE SEALED BOX FOR THE METER, THE PHARMACIST ASKED THE NURSE TO SEE IF THE LANCING DEVICE HAD A NAME ON IT. THE NURSE WAS NOT IN THE ROOM WITH THE PATIENT, SO THEN CALLED BACK TO TELL US IT WAS A ONE TOUCH DELICA DEVICE. THE PHARMACY THEN EXCHANGED THE LANCETS FOR THE PATIENT AFTER FINISHING THE EDUCATION WITH THE NURSE. (B)(4). SUBMISSION ID: (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
517749 ONETOUCH DELICA LANCETS SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE FMK ASAHI POLYSLIDER COMPANY, LIMITED OKAYAMA-KUSE PLANT

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown BLOOD GLUCOSE TEST STRIPS| ONETOUCH VERIO METER