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: NOVA BIOMEDICAL CORP. NOVA MAX LINK; BLOOD GLUCOSE TEST SYSTEM
  • 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
 

NOVA BIOMEDICAL CORP. NOVA MAX LINK; BLOOD GLUCOSE TEST SYSTEM Back to Search Results
Model Number 44585
Device Problems No Display/Image (1183); Missing Test Results (3267)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The nova max link blood glucose monitor is expected to be returned for evaluation.
 
Event Description
The complainant stated the last digit is missing from the results segment.
 
Manufacturer Narrative
The customer's complaint is confirmed.The plastic screen/cover of the lcd display is cracked on the upper right corner.The lcd is missing the following segments: all segments of the date characters.All segments of the third number.Battery icon,ctl and decimal point segments.Damage of this nature is consistent with the meter having been dropped.The dhr for the meter was complete and contained all relevant data indicating the product put into finished goods met all specifications.Nova biomedical will continue to monitor for recurrence as part of our post market surveillance program.File attachments.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NOVA MAX LINK
Type of Device
BLOOD GLUCOSE TEST SYSTEM
Manufacturer (Section D)
NOVA BIOMEDICAL CORP.
200 prospect st
waltham, ma
MDR Report Key10153120
MDR Text Key195101506
Report Number3004193489-2020-00006
Device Sequence Number1
Product Code NBW
UDI-Device Identifier00385480445856
UDI-Public00385480445856
Combination Product (y/n)N
PMA/PMN Number
K040603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number44585
Device Catalogue Number44585
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Date Manufacturer Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-