MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY ACL TOP 500 CTS

Model Number 2800-40

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

Patient Problem Therapeutic Response, Increased (2272)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

An investigation was conducted that included a review of the instrument clot curves.All aptt results illustrated well-formed curve formation, with appropriate clotting times detected and no concerning errors or warnings.The conclusion is that the values obtained on the acl top 500 cts were appropriately determined by the analyzer and the instrument was performing as intended.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 500 cts generated erroneous aptt results using hemosil synthasil.Four patients were administered an increased dose of heparin based on the erroneous aptt results.After the additional dose of heparin, the patients were monitored with no further reports of clinical implications.

• Brand Name: ACL TOP 500 CTS
• Type of Device: ACL TOP
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 8225762
• MDR Text Key: 132339970
• Report Number: 1217183-2019-00001
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• 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
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other