Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN, INC. ONETOUCH VERIO ; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIFESCAN, INC. ONETOUCH VERIO ; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER Back to Search Results
Model Number VERIO TEST STRIP-PACK OF 50
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2020
Event Type  malfunction  
Event Description
New pack of 50 lifescan onetouch verio glucose meter test strip lot #4510142 with 10/31/2020 expiration is defective and gives error.Open the package yesterday and all 4 test strips gave error saying use new strip.Even used level 3 control solution and same error.So opened another package with same lot number and it worked.Called lifescan at (b)(4) to report the incident and (b)(6) made no attempt to retrieve the defective test strip and said will send replacement which i declined.(b)(6) also told me not to report this to fda.Escalated to (b)(4) in (b)(4) call center and she did not know the name of (b)(6).How can (b)(6) tell me not to contact fda medwatch? fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ONETOUCH VERIO
Type of Device
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Manufacturer (Section D)
LIFESCAN, INC.
MDR Report Key10000618
MDR Text Key189167328
Report NumberMW5094267
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/23/2020
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/31/2020
Device Model NumberVERIO TEST STRIP-PACK OF 50
Device Lot Number4510142
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age57 YR
Patient Weight79
-
-