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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 29
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 5
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 19
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 61

Device Problems
Device displays error message 24965
Incorrect or inadequate test results 8650
Failure to power-up 5314
Loss of power 5252
Low test results 5008
High test results 4283
Device alarm system issue 3304
Filling problem 2979
No code available 2003
Battery issue 1962
No display or display failure 1884
Low battery 1801
Incorrect or inadequate result 1515
Loss of Data 1304
Device damaged prior to use 1124
Use of Incorrect Control Settings 964
No Information 853
Computer operating system issue 813
Component missing 766
Incorrect display 736
Reset issue 683
Image resolution poor 571
Poor quality image 550
Unable to obtain readings 532
Sticking 493
Melted 490
Device operates differently than expected 453
No Known Device Problem 422
Break 371
Output above specifications 362
Crack 361
Replace 345
Burn of device or device component 324
Incorrect software programming calculations 298
High Readings 282
Failure to calibrate 263
Defective component 248
False device output 248
Missing test results 233
User used incorrect product for intended use 231
Material discolored 199
Malfunction 188
False reading from device non-compliance 185
Image display error 172
Bent 172
Failure to obtain samples 158
Failure to back-up 125
Improper or incorrect procedure or method 118
Connector pin failure 113
Instruction for use issue 110
Error or warning message, failure to produce 108
Inadequate instructions for healthcare professional 100
Device Difficult to Setup or Prepare 94
Overheating of device or device component 90
Smoking 89
Inappropriate prompts 80
Device handling issue 75
Improper device output 75
Low readings 74
Self-activation or keying 74
Electrical issue 70
Defective item 69
Device inoperable 68
Dose calculation error due to software problem 68
Erratic display 67
Burst 65
Electrical shorting 53
Charging issue 49
Incorrect measurement 48
Date-related software issue 46
Incomplete or missing packaging 40
Unsealed device packaging 38
Use of Device Issue 34
Application interface becomes non-functional or program exits abnormally 30
Device ingredient or reagent issue 27
Charred 26
Material opacification 26
Unexpected therapeutic results 26
Timer failure 26
Device stops intermittently 25
Device expiration issue 25
Other (for use when an appropriate device code cannot be identified) 24
Data Issue 24
Device markings issue 21
Communication or transmission issue 20
Packaging issue 19
Difficult or delayed activation 19
Contamination during use 18
Unknown (for use when the device problem is not known) 17
Shelf life exceeded 17
Peeled 15
No device output 15
Output below specifications 15
Application program issue 15
Spark 14
Computer software issue 14
Calibration error 13
System fails to activate 13
Artifact 12
Failure to shut off 12
Total Device Problems 86882

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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