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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 12
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 10
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BAYER
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 7
BD
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
GENEXEL-SEIN, INC.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
HOME DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 7
HYPOGUARD, LTD.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
IDEAL LIFE INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 7
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 6
MEDAPPS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
NOVA
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 13
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 43

Device Problems
Low test results 3037
Filling problem 2978
Loss of Data 1285
Use of Incorrect Control Settings 899
Incorrect or inadequate test results 839
Computer operating system issue 811
Battery issue 707
Incorrect or inadequate result 703
Reset issue 678
Device displays error message 662
Unable to obtain readings 502
Melted 473
Failure to power-up 424
Poor quality image 419
Incorrect display 412
Break 360
Output above specifications 359
Replace 344
High test results 307
Burn of device or device component 287
False device output 246
Malfunction 188
Crack 158
Connector pin failure 114
Error or warning message, failure to produce 108
No display or display failure 92
Overheating of device or device component 85
Loss of power 83
Smoking 82
Device damaged prior to use 82
Electrical issue 68
Burst 63
Self-activation or keying 58
Material discolored 56
Electrical shorting 52
Inappropriate prompts 46
Improper or incorrect procedure or method 41
Device inoperable 38
Date-related software issue 38
Device operates differently than expected 36
Image resolution poor 34
High Readings 30
Incorrect measurement 27
Application interface becomes non-functional or program exits abnormally 27
Timer failure 26
Use of Device Issue 25
Erratic display 25
Other (for use when an appropriate device code cannot be identified) 24
Charred 24
Unexpected therapeutic results 22
Difficult or delayed activation 19
False reading from device non-compliance 18
Sticking 17
Unknown (for use when the device problem is not known) 17
Device expiration issue 16
Image display error 16
Shelf life exceeded 14
System fails to activate 13
Output below specifications 13
Computer software issue 12
Component missing 12
Artifact 12
Improper device output 11
Defective component 10
Spark 10
Corrosion 9
Failure to shut off 8
No Information 8
Mechanical issue 7
Difficult to Program or Calibrate 7
No Known Device Problem 6
Interference 6
Device Cleaning Issue 5
Device remains activated 5
Failure, intermittent 5
Battery failure 5
Premature discharge of battery 4
Explode 4
Mislabeled 4
No code available 4
Mechanical jam 4
Human-Device Interface Issue 4
Fire 4
Application program issue 4
Communication or transmission issue 4
Incorrect software programming calculations 4
Failure to obtain samples 4
Failure to back-up 3
Fail-safe design failure 3
Low readings 3
Out-of-box failure 3
Material opacification 3
Incorrect error code 3
Retraction problem 3
Calibration error 3
Low battery 3
Manufacturing or shipping issue associated with device 2
Meter failure 2
Component falling 2
Timer malfunction 2
Total Device Problems 18844

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

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

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