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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 63
Output issue 34
Problem with software installation 31
Incorrect or inadequate result 24
Computer software issue 21
Patient Data Issue 17
High test results 11
Device operates differently than expected 10
Data Issue 9
Programming issue 9
Improper or incorrect procedure or method 6
Burn of device or device component 5
Charred 5
False negative result 4
Device Issue 4
Incorrect software programming calculations 4
No Known Device Problem 4
Incorrect or inadequate test results 3
Low test results 3
Spark 1
Failure to fire 1
Implant Mobility NOS (Not otherwise specified) 1
Application program issue 1
Loss of Data 1
Device sensing issue 1
Scratched material 1
Positioning Issue 1
Device handling issue 1
Metal shedding debris 1
Malfunction 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Fire 1
Mechanical issue 1
Melted 1
Device emits odor 1
Unintended system motion 1
Overheating of device or device component 1
Component(s), worn 1
Contamination during use 1
Dose calculation error due to software problem 1
Total Device Problems 289

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

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

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