MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY ACL TOP 500 CTS; ACL TOP, PRODUCT CODE: GKP

Model Number 2800-40

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

Patient Problem Therapeutic Response, Increased (2272)

Event Date 04/08/2017

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 500 cts 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

Customer reported that their acl top 500 cts reported erroneous aptt patient results using hemosil synthasil.Six patient samples generated erroneous results.One patient was administered an unnecessary bolus of heparin due to the aptt result being lower than expected.All six samples were subsequently corrected and there were no reported serious adverse events.

• Brand Name: ACL TOP 500 CTS
• Type of Device: ACL TOP, PRODUCT CODE: GKP
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: shari o'connor ; 180 hartwell road; bedford, MA 01730 ; 7818614364
• MDR Report Key: 6885953
• MDR Text Key: 87201620
• Report Number: 1217183-2017-00005
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2800-40
• Device Catalogue Number: 00000280040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2010
• 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): Other