MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 500; COAGULATION ANALYZER

Model Number 2800-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/09/2014

Event Type  Death  

Event Description

On (b)(6) 2014, the customer called to question a pt's clauss fibrinogen result using hemosil q.F.A.Thrombin on their acl top 500 cts instrument.The sample was drawn on (b)(6) 2014, and gave a fibrinogen result of 183 mg/dl.Daily maintenance was performed on the instrument and qc was in range before and after the sample was drawn.The sample was draw at 12:10 pm and frozen at 2:00 pm.The frozen sample was defrosted four days post draw and thawed at 37 degrees celsius for four minutes.The thawed, diluted, sample was run in the q/f/a/ test at 11/35 on 03/13 and failed.Ti was then tested again as a neat sample at 11:36 and a result of 332 mg/dl was obtained.The sample was then tested in the q.F.A.Low test and a result of 67 mg/dl was obtained.The pt died on (b)(6) 2014.There is no indication from the customer that the fibrinogen result of 183 mg/dl was related to the pt death.

Manufacturer Narrative

An internal evaluation has been performed with the reagent lot of hemosil q.F.A.Thrombin in use at the customer site.The evaluation showed that the test successfully calibrated and recovered means for all control sets within their ranges.To complete the investigation, instrumentation laboratory co.Is awaiting the data back-up from the acl top 500 cts in use at the customer site.Several requests have been made for the back-up and we will submit a follow-up report when this additional info is received.There is no indication to date that the hemosil q.F.A.Thrombin result was a contributing factor in the pt death.

• Brand Name: ACL TOP 500
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; bedford MA
• Manufacturer Contact: carl marble ; 180 hartwell road; bedford, MA 01730 ; 7818614467
• MDR Report Key: 3760662
• MDR Text Key: 4551590
• Report Number: 1217183-2014-00003
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K07337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2800-40
• Device Catalogue Number: 0000280040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death