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 01/28/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, an instrumentation laboratory representative became aware of an incident that occurred at (b)(6) on (b)(6) 2014.The customer indicated that their acl top 500 cts reported 17 erroneous aptt results using hemosil synthasil.Per their description of the event, the first patient sample contained a clot and they believe that it contaminated the instrument, causing the erroneous 17 test results.Of the affected patient samples, 4 of 17 were heparinized patients.As a result, 3 of the 4 patients had their heparin dosage changed based on the incorrect aptt results.All were subsequently corrected when the samples were repeated and corrected results obtained.There were no associated adverse events with this sample handling issue.

Manufacturer Narrative

The site has instituted some safeguards in their laboratory that include repeating any aptt value of <20 seconds on a second analyzer, and including delta checks in their lis system to flag results that are noted to be beyond the normal variation of sample to sample differences.This issue appears to have been well characterized by the site and appropriate action has been taken to recognize aberrant values and assess the need to retest.There was no indication of an instrument or reagent malfunction.Therefore, no remedial action is required by instrumentation laboratory co.

• Brand Name: ACL TOP 500 CTS
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; bedford MA
• Manufacturer Contact: carole marble ; 180 hartwell road; bedford, MA 01730 ; 7818614467
• MDR Report Key: 3940540
• MDR Text Key: 18794970
• Report Number: 1217183-2014-00005
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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