FDA Adverse Event Injury Summary report: N

ACL TOP 700

MDR report key: 7064403 · Received November 28, 2017

Report

Report Number: 1217183-2017-00007
Event Type: Injury
Date Received: November 28, 2017
Date of Event: October 29, 2017
Report Date: November 27, 2017
Manufacturer: INSTRUMENTATION LABORATORY
Product Code: GKP
UDI-DI: 08426950497974
PMA / PMN Number: K160276
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
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 700 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

A CUSTOMER REPORTED THAT THEIR ACL TOP 700 REPORTED 2 ERRONEOUSLY LOW APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. ONE PATIENT WAS GIVEN ADDITIONAL HEPARIN DUE TO THE LOWER RESULTS. HOWEVER, THERE WAS NO ADVERSE EFFECTS DUE TO THE EXTRA HEPARIN. THE RESULTS DID NOT MATCH PATIENT HISTORY AND WAS THEREFORE REPEATED. THE 2 SAMPLES WERE SUBSEQUENTLY CORRECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
844316	ACL TOP 700	ACL TOP	GKP	INSTRUMENTATION LABORATORY	2800-10		08426950497974

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR