FDA Adverse Event Injury Summary report: N

ACL TOP 500 CTS

MDR report key: 6885953 · Received September 22, 2017

Report

Report Number: 1217183-2017-00005
Event Type: Injury
Date Received: September 22, 2017
Date of Event: April 8, 2017
Report Date: September 22, 2017
Manufacturer: INSTRUMENTATION LABORATORY
Product Code: GKP
UDI-DI: 08426950453499
PMA / PMN Number: K160276
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AN INVESTIGATION WAS CONDUCTED THAT INCLUDED A REVIEW OF THE INSTRUMENT DATA. REVIEW OF THE DATA CONCLUDED THAT THE VALUES OBTAINED ON THE ACL TOP 500 CTS WERE APPROPRIATELY DETERMINED BY THE ANALYZER AND THE INSTRUMENT WAS PERFORMING AS INTENDED. WHILE THE ROOT CASE CANNOT BE DETERMINED, THERE ARE MANY VARIABLES THAT HAVE THE POTENTIAL TO INFLUENCE THE RESULT RECOVERIES. THESE MAY INCLUDE, BUT NOT LIMITED TO, THE ACCURACY OF THE RECONSTITUTION OF THE REAGENTS AND CLEANING MATERIALS USED, THE ONBOARD STABILITY OF MATERIALS USED, REAGENT AND/OR SAMPLE HANDLING, AND SAMPLE INTEGRITY ALL OF WHICH COULD HAVE CONTRIBUTED TO THE GENERATED FINDINGS. BASED ON THE ABOVE, THERE WAS NO INDICATION OF AN INSTRUMENT MALFUNCTION AND NO REMEDIAL ACTION IS NEEDED.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. SIX PATIENT SAMPLES GENERATED ERRONEOUS RESULTS. ONE PATIENT WAS ADMINISTERED AN UNNECESSARY BOLUS OF HEPARIN DUE TO THE APTT RESULT BEING LOWER THAN EXPECTED. ALL SIX SAMPLES WERE SUBSEQUENTLY CORRECTED AND THERE WERE NO REPORTED SERIOUS ADVERSE EVENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
666124	ACL TOP 500 CTS	ACL TOP, PRODUCT CODE: GKP	GKP	INSTRUMENTATION LABORATORY	2800-40		08426950453499

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other