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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, blood glucose, over the counter
Regulation Description Glucose test system.
Product CodeNBW
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 30
AGAMATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 16
BD
  SUBSTANTIALLY EQUIVALENT 3
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENEXEL-SEIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOME DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 10
HYPOGUARD, LTD.
  SUBSTANTIALLY EQUIVALENT 2
IDEAL LIFE INC.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 13
MEDAPPS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
NOVA
  SUBSTANTIALLY EQUIVALENT 6
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 19
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 61

Device Problems
Device displays error message 25184
Incorrect or inadequate test results 10746
Failure to power-up 8445
Low test results 5362
Loss of power 5281
High test results 4739
Device alarm system issue 3321
Filling problem 2979
No code available 2025
Battery issue 1985
No display or display failure 1968
Low battery 1809
Incorrect or inadequate result 1666
Loss of Data 1305
Device damaged prior to use 1125
Use of Incorrect Control Settings 964
No Information 855
Computer operating system issue 813
Component missing 766
Incorrect display 749
Reset issue 683
No Known Device Problem 580
Image resolution poor 574
Poor quality image 550
Unable to obtain readings 532
Melted 498
Sticking 495
Device operates differently than expected 468
Break 371
High Readings 369
Crack 363
Output above specifications 362
Replace 345
Incorrect software programming calculations 340
Burn of device or device component 328
Failure to calibrate 264
Defective component 251
False device output 248
User used incorrect product for intended use 236
Missing test results 235
Material discolored 200
Malfunction 188
False reading from device non-compliance 185
Image display error 177
Bent 172
Failure to obtain samples 159
Failure to back-up 125
Improper or incorrect procedure or method 120
Device handling issue 118
Connector pin failure 113
Instruction for use issue 110
Error or warning message, failure to produce 108
Low readings 107
Inadequate instructions for healthcare professional 100
Device Difficult to Setup or Prepare 94
Smoking 92
Overheating of device or device component 90
Inappropriate prompts 80
Improper device output 75
Self-activation or keying 74
Dose calculation error due to software problem 72
Electrical issue 70
Defective item 70
Device inoperable 68
Erratic display 67
Burst 65
Electrical shorting 54
Incorrect measurement 51
Charging issue 49
Date-related software issue 47
Unsealed device packaging 42
Incomplete or missing packaging 40
Use of Device Issue 35
No device output 34
Application interface becomes non-functional or program exits abnormally 31
Unexpected therapeutic results 30
Device ingredient or reagent issue 27
Data Issue 27
Timer failure 26
Charred 26
Material opacification 26
Device expiration issue 25
Device stops intermittently 25
Other (for use when an appropriate device code cannot be identified) 24
Device markings issue 21
Communication or transmission issue 21
Packaging issue 19
Difficult or delayed activation 19
Contamination during use 18
Calibration error 17
Unknown (for use when the device problem is not known) 17
Shelf life exceeded 17
Peeled 17
Output issue 16
Output below specifications 15
Application program issue 15
Computer software issue 15
Spark 14
Failure to shut off 13
System fails to activate 13
Total Device Problems 93964

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 4 0 0 0 2 0 4 1 0 0 0
Class II 4 2 4 3 1 1 4 3 0 2 0
Class III 1 2 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. I Mar-18-2014
2 Abbott Diabetes Care, Inc. I Dec-17-2013
3 Abbott Diabetes Care, Inc. I May-09-2013
4 Abbott Diabetes Care, Inc. II Feb-15-2011
5 Abbott Diabetes Care, Inc. I Feb-09-2011
6 Abbott Diabetes Care, Inc. II Sep-01-2009
7 Abbott Diabetes Care, Inc. II Feb-14-2008
8 Abbott Diabetes Care, Inc. III Jun-07-2007
9 Abbott Diabetes Care, Inc. II May-23-2007
10 Core Care Technologies, Inc I Jan-05-2007
11 Discount Diabetic Supply I Jan-05-2007
12 Invictus Scientific Inc III Feb-16-2008
13 Lifescan Inc I Apr-12-2013
14 Lifescan Inc II Oct-01-2010
15 Lifescan Inc II Jul-17-2010
16 Lifescan Inc II Mar-17-2009
17 Lifescan Inc II Nov-21-2008
18 Lifescan Inc III Apr-08-2008
19 Lifescan Inc II Jul-13-2007
20 Lifescan Inc II Jan-05-2007
21 Livongo Health II Apr-29-2016
22 Matrix Distributors, Inc. I Feb-14-2007
23 Nipro Diagnostics, Inc. II Feb-03-2014
24 Nipro Diagnostics, Inc. II Apr-18-2013
25 Nova Biomedical Corporation I Aug-09-2013
26 Oak Tree International Holdings, LLC, Inc. II Sep-10-2009
27 Polymer Technology Systems, Inc. II May-25-2013
28 Polymer Technology Systems, Inc. II Sep-30-2010
29 Roche Diagnostics Corp. II Sep-16-2009
30 Roche Diagnostics Operations, Inc. II May-13-2014
31 Roche Diagnostics Operations, Inc. II Nov-22-2013
32 Roche Diagnostics Operations, Inc. II Apr-15-2013
33 Roche Diagnostics Operations, Inc. II Apr-09-2012
34 Roche Diagnostics Operations, Inc. I Jun-21-2011
35 Safety & Supplies Co. Inc. I Mar-03-2007
36 Smith & Nephew, Inc. Endoscopy Division II Apr-07-2007
37 Trividia Health II Sep-23-2016
38 Unistrip Technologies LLC II Dec-23-2014

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