FDA Adverse Event Other Summary report: N

IMX STAT CK-MB REAGENT

MDR report key: 129180 · Received October 27, 1997

Report

Report Number: 2623532-1997-00024
Event Type: Other
Date Received: October 27, 1997
Date of Event: September 25, 1997
Report Date: October 24, 1997
Manufacturer: ABBOTT HEALTH PRODUCTS, INC.
Product Code: JHY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT EVALUATION: A CUSTOMER RETURN WAS NOT RECEIVED. IN ORDER TO INVESTIGATE THIS COMPLAINT, A CALIBRATION CURVE WAS RUN FOLLOWED BY A MODE-1 RUN, USING THE SAME REAGENT AS THE CUSTOMER. THIS WAS PERFORMED ON ONE IMX TO DETERMINE IF ANY CONTROLS OR PANELS WERE ELEVATED. A SUMMARY OF THE INVESTIGATION INDICATED ALL CONTROLS AND PANEL VALUES WERE WITHIN THE PACKAGE INSERT RANGES. ALL OF THE PANEL VALUES WERE WITHIN THE IN-HOUSE SPECIFICATIONS. NO CORRECTIVE ACTION IS NECESSARY. THIS IS THE FINAL REPORT.

Description of Event or Problem · 1

ON 9/25/1997 THE ACCOUNT REPORTED A FALSELY ELEVATED CK-MB RESULT OF 15.1 NG/ML ON A PATIENT, WHO HAD A PREVIOUS CK-MB RESULT OF 2.6 NG/ML. A THIRD SAMPLE ON THE PATIENT GAVE A RESULT OF 1.5 NG/ML. THE SECOND RESULT WAS QUESTIONED BY THE TECHNICIAN RUNNING THE THIRD SAMPLE AND THE SECOND SAMPLE WAS RETESTED, GIVING A RESULT OF 2.5 NG/ML. THE SECOND SAMPLE WAS SERUM AND HAD CLOTTED BETWEEN THE ORIGINAL RUN AND THE RETEST. THE ACCOUNT BELIEVES THE SECOND SAMPLE MAY HAVE CLOTTED IN THE SAMPLE CUP DURING THE ORIGINAL RUN. THE PATIENT WAS NOT TREATED BASED UPON THE FALSELY ELEVATED RESULT. NO REPORT OF INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IMX STAT CK-MB REAGENT	MEIA FOR THE MEASUREMENT OF CK-MB	JHY	ABBOTT HEALTH PRODUCTS, INC.	NA	27630Q100

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR			IMX ANALYZER