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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 60

Device Problems
Device displays error message 19883
Incorrect or inadequate test results 7022
Low test results 4928
Loss of power 4059
High test results 3922
Filling problem 2979
Failure to power-up 2897
Device alarm system issue 2498
No display or display failure 1707
Battery issue 1694
No code available 1546
Incorrect or inadequate result 1447
Low battery 1342
Loss of Data 1302
Use of Incorrect Control Settings 964
Device damaged prior to use 906
Computer operating system issue 813
Incorrect display 707
Reset issue 683
No Information 680
Component missing 620
Poor quality image 550
Unable to obtain readings 530
Melted 488
Device operates differently than expected 446
Image resolution poor 403
Sticking 381
Break 371
Output above specifications 362
Replace 345
Burn of device or device component 320
Crack 307
No Known Device Problem 265
Incorrect software programming calculations 263
High Readings 263
False device output 248
Failure to calibrate 209
Defective component 190
Malfunction 188
False reading from device non-compliance 185
User used incorrect product for intended use 181
Missing test results 174
Image display error 171
Material discolored 162
Bent 134
Failure to obtain samples 129
Connector pin failure 113
Error or warning message, failure to produce 108
Improper or incorrect procedure or method 107
Failure to back-up 91
Overheating of device or device component 90
Smoking 88
Instruction for use issue 86
Inappropriate prompts 80
Device Difficult to Setup or Prepare 75
Inadequate instructions for healthcare professional 75
Improper device output 75
Self-activation or keying 74
Electrical issue 70
Device inoperable 67
Low readings 66
Burst 65
Dose calculation error due to software problem 63
Device handling issue 63
Defective item 62
Erratic display 61
Electrical shorting 53
Charging issue 49
Incorrect measurement 46
Date-related software issue 44
Incomplete or missing packaging 33
Use of Device Issue 32
Application interface becomes non-functional or program exits abnormally 30
Device ingredient or reagent issue 27
Charred 26
Unsealed device packaging 26
Timer failure 26
Unexpected therapeutic results 25
Device stops intermittently 25
Device expiration issue 25
Other (for use when an appropriate device code cannot be identified) 24
Data Issue 23
Device markings issue 21
Material opacification 20
Difficult or delayed activation 19
Packaging issue 19
Unknown (for use when the device problem is not known) 17
Contamination during use 17
Shelf life exceeded 16
Output below specifications 15
Application program issue 15
Communication or transmission issue 15
Spark 14
System fails to activate 13
Peeled 13
Computer software issue 12
Artifact 12
Failure to shut off 12
Calibration error 11
Cut in material 11
Total Device Problems 72229

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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