MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY ACL TOP 700

Model Number 2800-10

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

Patient Problem Therapeutic Response, Increased (2272)

Event Date 10/29/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ACL TOP 700
• Type of Device: ACL TOP
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell rd; bedford MA 01730
• Manufacturer Contact: shari o'connor ; 180 hartwell rd; bedford, MA 01730 ; 7818614364
• MDR Report Key: 7064403
• MDR Text Key: 93117786
• Report Number: 1217183-2017-00007
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950497974
• UDI-Public: 08426950497974
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: 2800-10
• Device Catalogue Number: 00000280010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR