Problems with Medical Devices Used in Point-of-Care Testing
MedSun: Newsletter #30, November 2008

Lynn Henley, M.S., M.B.A., Mingdong Zhang, M.D., Ph.D., Ruth Chesler, M.T., and Ann Chappie, M.T., Center for Devices and Radiological Health, Food and Drug Administration

This is the second in a series of articles discussing point-of-care (POC) testing in the clinical setting. The first provided an overview of point-of-care testing (http://www.fda.gov/cdrh/medsun/.) The second will address adverse event data regarding point-of-care devices received in the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Medical Device Reporting (MDR)/Manufacturer and User Facility Device Event (MAUDE) database.

A search for adverse event data was conducted on June 2, 2008, consisting of the most common problems reported to the Office of In Vitro Diagnostic Devices (OIVD) in CDRH for a two-year period. The CDRH MAUDE database was searched to find the top 100 reported medical device problems, excluding those with glucose meters, occurring for point-of-care devices during the period from June 1, 2006 through June 2, 2008. Glucose meters are currently responsible for the majority of adverse event problems received for point-of-care devices. This data was excluded due to coverage of the subject in a recent article in the MedSun newsletter entitled, “Analysis of Glucose Meter Medical Device Reporting (MDR)/MAUDE Database,” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news+21. This article discusses the 10,000 reports received annually involving glucose meters. The reports capture serious adverse events including malfunction, injury and death. The majority of the reports cite inaccurate readings as the problem. FDA is currently working to determine major causes for inaccurate readings of glucose meters and to identify solutions.

Other than reports for glucose meter problems, there were 3,742 reports received by OIVD/CDRH in the MAUDE database during this two-year period. Please note that the CDRH MAUDE database is not representative of all problems that exist with POC devices but is representative of those problems that have been reported. Furthermore, the products listed may or may not be the most commonly-occurring devices in the marketplace. The following products comprise the balance of devices with problems reported in this data search:

Table 1. Point-of-Care devices from Top 100 In Vitro Diagnostic devices listing of adverse events identified in June 2006 to June 2008 data search by product.

PT/INR Testing Systems I, II, and III	Point-of-Care Blood Analyzer 6+ Cartridge
PT/INR Testing Strips	Point-of-Care Blood Analyzer CREA Cartridge
Pregnancy Test I and II	Point-of-Care Blood Analyzer CTNI Cartridge
Home Pregnancy Test I and II	Point-of-Care Blood Analyzer
”25” Pregnancy Test	Human Chorionic Gonadotropin Test System

Within this product group, the most commonly-reported device problems were “replace” (1030 reports or 27.5%), “results inaccurate” (1823 reports or 48.8%), and “high readings/test results” (595 reports or 15.9%). The results of the data search are summarized in Table 2. Please note that device descriptions are listed below the table.

Table 2. Commonly reported problems with point-of-care devices with greater than 10% incidence listed by device name (June 2006 - June 2008).*

Replace	Replace as % of All Problem Codes for this Device	Results Inaccurate	Results Inaccurate as % of All Problem Codes for this Device	High Readings/Test Results	High Readings/Test Results as % of All Problem Codes for this Device	False Positive Test Results	False Positive Test Results as % of All Problem Codes for this Device	Other Problems**	Total
DEVICE NAME:
I. Coagulation Devices
CoaguChek S System	958	30.8%	1501	48.2%	489	14.5%	0	0%	164	3112
CoaguChek Strips	0	0%	1	20%	2	40%	0	0%	2	5
CoaguChek System	24	28.9%	35	42.2%	16	15.7%	0	0%	8	83
CoaguChek XS System	43	14.7%	235	80.5%	11	3.4%	0	0%	3	292
II. Pregnancy Kits
Confirm Clearly	0	0%	0	0%	0	0%	10	90.9%	1	11
Confirm Clearly Home Pregnancy Test	0	0%	0	0%	0	0%	1	100%	0	1
Confirm Clearly Smart Home Pregnancy Test	0	0%	0	0%	0	0%	1	100%	0	1
Confirm Clearly Smart Pregnancy Test	0	0%	0	0%	0	0%	2	100%	0	2
Icon 25 HCG	0	0%	0	0%	0	0%	0	0%	21	21
III. Critical Care Analyzers
i-STAT 6+ Cartridge	1	6.3%	2	12.5%	0	0%	0	0%	13	16
i-STAT CREA Cartridge	0	0%	0	0%	0	0%	0	0%	14	14
i-STAT CTNI Cartridge	0	0%	25	59.5%	10	23.8%	0	0%	7	42
i-STAT PT/INR Cartridge	1	3.6%	4	14.3%	19	67.9%	0	0%	4	28
Stratus CS Stat Fluorometric Analyzer	3	2.7%	20	17.7%	46	40.7%	0	0%	44	113
TOTAL	1030	27.5%	1823	48.8%	593	15.91%	14	0.8%	282	3742

*Device Descriptions

CoaguChek (Roche): CoaguChek is a portable analyzer that tests prothrombin time.

Confirm Clearly (Mizuho): Confirm Clearly is a pregnancy test. It is no longer on the market.

Icon 25 hCG (Beckman Coulter): Icon 25 HCG is a portable pregnancy tester.

i-Stat (Abbott): i-Stat is a portable blood gas and critical care analyzer that tests blood gases, electrolytes, chemistries, coagulation, cardiac markers, and hematology. The 6+ cartridge tests sodium, potassium, chloride, BUN, glucose, hematocrit, and hemoglobin; the CREA cartridge tests creatinine; the cTnl cartridge tests troponin; and the PT/INR cartridge tests prothrombin time.

Stratus CS Stat Fluorometric Analyzer (Siemens): The Stratus CS Stat Fluorometric Analyzer is a portable analyzer of cardiac markers.

The problem codes listed below in Table 3 represent those problems least commonly reported (<10%):

Table 3. Listing of all codes falling into “other” category from Table 2.

1. Incomplete aspiration 2. Clogged 3. Coagulation 4. Broken components 5. False claim 6. False-negative test result 7. False-positive test result 8. False readings 9. Filling problem 10. Interference 11. Melts 12. Misassembly 13. Misplacement 14. Nonstandard	15. Occlusion 16. Puncture 17. Unable to obtain readings 18. Repair 19. Failure to retract 20. Rupture due to damage from surgical instrument 21. Slippage 22. Accidental spillage 23. Incorrect device 24. Improper/incorrect procedure 25. Other (for use when an appropriate device code cannot be identified)	26. Unknown (for use when the device problem is not known) 27. Blood contaminated device 28. Residue 29. Failure to deliver 30. Malfunction 31. Obstruction 32. Cut(s) 33. Low readings/test results 34. Error message given 35. Difficult to close 36. Folding issue

This data search is the first step in looking at typical problems with point-of-care devices. The problems identified here reflect the need for the laboratory community to ensure that quality controls are in place. For instance, the most common problem identified was replacing equipment or equipment components. If this as well as other quality controls are in place, some of the reported problems could be minimized.

Reporting adverse events to FDA will also minimize POC device problems. As a result of increased reporting by the laboratory community, FDA will be able to work together with healthcare professionals and manufacturers to ensure that our database is more reflective of the types of problems seen in the clinical community so that these issues can be addressed in order to protect the public health.

Acknowledgments are made to Marilyn Flack, Donna Engleman, and Christine King, Center for Devices and Radiological Health, Food and Drug Administration.

Reference:
U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting Manufacturer and User Facility Device Event Database. Retrieved June 2, 2008, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm.

Additional Information:

Problems with Medical Devices Used in Point-of-Care Testing. By Lynn Henley, M.S., et al. October 2008.