FDA Adverse Event Malfunction Summary report: N

EPOC BGEM TEST CARD

MDR report key: 2396266 · Received November 28, 2011

Report

Report Number: 3004959793-2011-00004
Event Type: Malfunction
Date Received: November 28, 2011
Date of Event: October 28, 2011
Report Date: November 28, 2011
Manufacturer: EPOCAL INC.
Product Code: CHL
PMA / PMN Number: K061597
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SINGLE USE TEST CARD IN QUESTION WAS NOT RETURNED NOR WAS THE ACTUAL TEST DATA FROM THE EPOC DEVICE MADE AVAILABLE. EPOCAL REVIEWED THEIR TEST CARD LOT DATA AND CONCLUDED THAT THE CHANCES OF SUCH A DISCREPANCY WAS HIGHLY UNLIKELY. THERE WERE NO REPORTS OF SIMILAR PROBLEMS WITH THIS PARTICULAR CARD LOT. PUBLISHED LITERATURE INDICATES THAT THE MAIN CAUSE FOR POTASSIUM DISCREPANCIES IS THE HEMOLYSIS OF THE BLOOD SAMPLE. WE CONCLUDE THAT, WHILE POSSIBLE FOR AN EPOC K TEST RESULT TO READ HIGH BY OVER 1TE, THE CHANCES FOR AN EPOC K READING TO BE OVERESTIMATED BY MORE THAN 0.5MM ARE IN THE ORDER OF TENS OF PARTS PER MILLION AND THEREFORE WE CONCLUDE THAT THE DISCREPANCY SEEN BY THE CUSTOMER IS FAR MORE LIKELY DUE TO PRE-ANALYTICAL ERROR, I.E. HEMOLYSIS DURING OR AFTER THE DRAW.

Description of Event or Problem · 1

EMERGENCY UNIT CAME AT HOME AND USED EPOC. WOMAN OF (B)(6) WITH ATRIOVENTRICULAR BLOCK (AVB). EPOC RESULT WAS 7.4 MMOL/L. SO PHYSICIAN GIVE TREATMENT INSULIN, AND TREATMENT AGAINST HIGH K (POTASSIUM). THEY USED HEPARIN SYRINGE FOR EPOC SYSTEM WITH ARTERIAL BLOOD. RESULT FOR LAB = 4.5MMOL/L. THEY USED EDTA AND VENOUS BLOOD FOR THE OTHER SYSTEM (RADIOMETER ABL 800).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EPOC BGEM TEST CARD	CHL, CEM, JFP, JPI, JGS, CGA, KHP	CHL	EPOCAL INC.	EPOC BGEM	07-11192-00

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Other