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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calculator/data processing module, for clinical use
Regulation Description Calculator/data processing module for clinical use.
Product CodeJQP
Regulation Number 862.2100
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 5
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 64
Output issue 47
Problem with software installation 32
Computer software issue 27
Incorrect or inadequate result 25
Patient Data Issue 21
No Known Device Problem 19
Data Issue 17
High test results 15
Device operates differently than expected 13
Programming issue 9
Improper or incorrect procedure or method 8
Charred 8
False negative result 6
Burn of device or device component 5
Incorrect software programming calculations 5
Incorrect or inadequate test results 5
Device Issue 5
Application program issue 4
Low test results 4
Smoking 2
Mechanical issue 2
Melted 2
Use of Incorrect Control Settings 2
Device handling issue 2
Positioning Issue 1
Scratched material 1
No code available 1
Dose calculation error due to software problem 1
Fire 1
Component(s), worn 1
Contamination during use 1
Device emits odor 1
Unintended system motion 1
Overheating of device or device component 1
Spark 1
Failure to fire 1
Implant Mobility NOS (Not otherwise specified) 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Metal shedding debris 1
Connection issue 1
Loss of Data 1
Malfunction 1
Device sensing issue 1
Material integrity issue 1
Total Device Problems 370

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 3 6 6 5 6 14 5 12 10 5 2
Class III 0 0 0 1 0 6 2 3 1 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Sep-18-2009
2 Abbott Laboratories, Inc II Feb-05-2009
3 Abbott Laboratories, Inc II Jan-25-2008
4 Abbott Laboratories, Inc II Nov-24-2007
5 Abbott Laboratories, Inc II Jul-03-2007
6 Abbott Point of Care Inc. II Feb-26-2010
7 Beckman Coulter Inc II Jan-09-2007
8 Beckman Coulter Inc. III Jan-18-2017
9 Cerner Corp II May-01-2009
10 Data Innovations, Inc. II Dec-24-2013
11 Data Innovations, Inc. II Oct-21-2011
12 Data Innovations, LLC II Sep-12-2014
13 GE Healthcare Integrated IT Solutions II May-15-2009
14 GE Healthcare Integrated IT Solutions II Dec-31-2008
15 GE Healthcare It II Aug-26-2016
16 GE Healthcare It III Jan-29-2014
17 GE Healthcare It II Jan-02-2014
18 GE Healthcare It II Nov-15-2013
19 GE Healthcare It II Jun-24-2013
20 Ge Healthcare It III Jun-26-2015
21 Ge Healthcare It II Jun-14-2011
22 Ge Healthcare It II Feb-15-2011
23 Ge Healthcare It II Oct-22-2010
24 Horiba Instruments, Inc dba Horiba Medical II Mar-11-2014
25 Horiba Instruments, Inc dba Horiba Medical III Apr-03-2013
26 Horiba Instruments, Inc dba Horiba Medical II Jan-07-2013
27 International Technidyne Corporation III Sep-20-2010
28 McKesson Technologies, Inc. II Jul-27-2015
29 Medical Information Technology, Inc. II Mar-19-2014
30 Medical Information Technology, Inc. II Mar-03-2014
31 Medical Information Technology, Inc. II Apr-26-2012
32 Merge Healthcare, Inc. II Nov-11-2016
33 Microsoft Corporation Health Solutions Group III Jun-04-2012
34 Microsoft Corporation Health Solutions Group II Mar-08-2012
35 Microsoft Corporation Health Solutions Group II Feb-22-2012
36 Microsoft Corporation Health Solutions Group II Jan-11-2012
37 Perkin Elmer II Aug-25-2009
38 Perkin Elmer Life Sciences Inc II Oct-26-2015
39 PerkinElmer Health Sciences, Inc. II Dec-23-2016
40 PerkinElmer Health Sciences, Inc. II Aug-07-2014
41 Radiometer America Inc II Sep-06-2014
42 Roche Diabetes Care, Inc. II Apr-02-2015
43 Roche Diagnostics Corp. II May-20-2009
44 Roche Diagnostics Corporation II Jan-24-2017
45 Roche Diagnostics Operations, Inc. II Oct-25-2016
46 Roche Diagnostics Operations, Inc. II Mar-23-2016
47 Roche Diagnostics Operations, Inc. II Nov-18-2015
48 Roche Diagnostics Operations, Inc. II Sep-01-2014
49 SCC Soft Computer II Feb-09-2015
50 SCC Soft Computer II Feb-02-2015
51 SCC Soft Computer II May-09-2014
52 SCC Soft Computer II Aug-03-2012
53 SCC Soft Computer II Jan-11-2012
54 SCC Soft Computer II Jan-11-2012
55 SCC Soft Computer III Jan-11-2012
56 SCC Soft Computer II Dec-02-2011
57 SCC Soft Computer II Nov-21-2011
58 SCC Soft Computer II Nov-17-2011
59 SCC Soft Computer II Nov-16-2010
60 SCC Soft Computer II Nov-15-2010
61 SCC Soft Computer II Nov-10-2010
62 SCC Soft Computer II Sep-22-2008
63 SCC Soft Computer II Sep-22-2008
64 Siemens Healthcare Diagnostics Inc III Jul-17-2014
65 Siemens Healthcare Diagnostics, Inc. II Feb-15-2017
66 Siemens Healthcare Diagnostics, Inc. II Jul-02-2015
67 Siemens Healthcare Diagnostics, Inc. II Jun-30-2015
68 Siemens Healthcare Diagnostics, Inc. II Jan-15-2015
69 Siemens Healthcare Diagnostics, Inc. II Sep-01-2014
70 Siemens Healthcare Diagnostics, Inc. II Jun-30-2014
71 Siemens Healthcare Diagnostics, Inc. II Jan-24-2014
72 Siemens Healthcare Diagnostics, Inc. II Aug-31-2012
73 Siemens Healthcare Diagnostics, Inc. II Aug-22-2012
74 Sunquest Information Systems, Inc. II Nov-06-2012
75 Sunquest Information Systems, Inc. II Nov-06-2012
76 Sunquest Information Systems, Inc. III Oct-17-2012
77 Sunquest Information Systems, Inc. II Sep-07-2012
78 Sunquest Information Systems, Inc. II Aug-24-2012
79 Sunquest Information Systems, Inc. II Aug-24-2012
80 Sunquest Information Systems, Inc. III Aug-22-2012
81 Sunquest Information Systems, Inc. III Aug-21-2012
82 Sunquest Information Systems, Inc. III Aug-16-2012
83 Sunquest Information Systems, Inc. II Nov-12-2008
84 Sunquest Information Systems, Inc. II Oct-31-2008
85 Technidata S.A. III Mar-31-2014
86 Technidata S.A. III Jul-17-2013
87 Technidata S.A. II May-21-2013
88 bioMerieux, Inc. II Dec-16-2015

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