EST STAT PLUS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-08 for EST STAT PLUS * manufactured by Hema Technologies.

Event Text Entries

[3992645] We were unable to report a sed rate on a patient the crp is 0. 6. Clinical pathologist was doing sed rates on both of the two instruments we have. On one instrument one patient was giving values ~ 15 and on the other instrument the values were ~ 30. The process was repeated and the controls on both instruments and repeated testing on 6 patients with varied esr results. These patient and the controls are were the same on both instruments. The gi patient was the only one with this dichotomy. At this point we have no explanation for this difference but will be in contact with the company. The pathologist did notice on the history of the gi patient that the sed rate jumped back and forth between 10 and the mid 20s. At this point the pathologist was not at all sure that this jumping around is not due to which instrument we were using. We do not normally run specimens on both instruments. Pathologist did some research on crones at sed rate and was surprised to find out that, although infliximab normally makes the sed rate go down by decreasing the inflammation, in some patients it goes up even with a otherwise judged decrease in inflammation. Sed rate is a very indirect measurement of acute phase reactants in response to inflammation. Rbc have negative charges which push them apart. As the rbc become coated with fibrinogen or other proteins the negative charges are neutralized and the rbc can come together. As they come together the sedimentation rate goes up - they settle faster. Crp is an acute phase reactant itself and a more direct measure of the current level of inflammation. Crp rises more quickly and to a greater extent than esr and also returns to normal more rapidly (in a few days instead of weeks). Esr and crp taken together may be useful to look at acute inflammation in the setting of chronic inflammation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3513894
MDR Report Key3513894
Date Received2013-11-08
Date of Report2013-11-08
Date of Event2013-11-07
Report Date2013-11-08
Date Reported to FDA2013-11-08
Date Reported to Mfgr2013-12-11
Date Added to Maude2013-12-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEST STAT PLUS
Generic NameESR STAT PLUS
Product CodeJPH
Date Received2013-11-08
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerHEMA TECHNOLOGIES
Manufacturer Address10102 USA TODAY WAY HOLLYWOOD FL 33025 US 33025


Patients

Patient NumberTreatmentOutcomeDate
10 2013-11-08

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