MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 500 CTS; 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 08/11/2015

Event Type  Injury  

Manufacturer Narrative

The hemosil synthasil aptt reagent product insert indicates that the normal range when tested on the acl top is approximately 25.1 - 36.5 seconds.A value below the low end of the normal range (16.6) should suggest an issue with the sample, prompting review of the detail associated with the result (mabs reading, the curve delta, the derivative curves, any flagging).In addition, the instrument software has a feature which allows for auto-validation of results, with specific exceptions as defined by the site.By defining those exceptions the site can hold back results that meet criteria in the exception list, allowing for a review of those results and any associated flagging by the operator before being released from the laboratory.That list of exceptions includes any sample with a "dr (data reduction) error on measured results" or a "dr warning on measured results".The 16.6 sec result had a "dr warning on the measured result".This is believed to be a customer education issue with no malfunction of the instrument system.The instrument behaved appropriately by providing the correct flagging to all of the samples involved.The actions that led to the change in patient treatment appear to be due to the fact that the customer did not appropriately investigate the flagging associated with each of the samples.These customer education issues will be addressed in the complaint closure.Therefore, no remedial action is required.Back up reviewed.

Event Description

Customer reports a patient sample was obtained and tested in both the standard and extended mode with hemosil synthasil (aptt reagent) on the acl top xxx.In each case, the sample returned a failed result.The laboratory reported the aptt result as >180 seconds.Based on the >180 seconds reported, the patient's heparin administration was stopped.Approximately four hours later a second sample was obtained from the same patient.A value of 16.6 seconds was obtained when tested in the standard mode with hemosil synthasil (aptt reagent) on the instrument and the result released.There were multiple warning flags appended to the 16.6 second result.In response to the 16.6 second result, 150 units of heparin was administered to the patient.Following the administration of the heparin, the patient experienced a bleeding episode.The lab reviewed the sample that generated the 16.6 second result, retested it in both the standard and extended modes with hemosil synthasil (aptt reagent) on the acl top 500, and determined that the true result from the clot curve was >180 sec.A correction was reported to the floor.Corrective action (details unavailable from the customer) was initiated once the corrected result (>180 sec) was reported to the floor, and the patient was closely monitored.Beyond the bleeding episode, there was no report of other adverse event incurred by the patient who was subsequently discharged on (b)(6) 2015.

• Brand Name: ACL TOP 500 CTS
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer Contact: carol marble ; 180 hartwell road; bedford, MA 01730-2443 ; 7818614467
• MDR Report Key: 5101551
• MDR Text Key: 26715032
• Report Number: 1217183-2015-00003
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: 2800-40
• Device Catalogue Number: 00000280040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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): Life Threatening