MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY ACL TOP 550 CTS; INSTRUMENT, COAGULATION, AUTOMATED

Model Number	2800-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Therapeutic Response, Increased (2272)
Date of Event	02/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was conducted that included review of the instrument aptt clot curves along with the verification of sample and reagent fluidic precision.Aptt quality control was within passing criteria prior to patient testing and immediately after the questionable results were generated.The conclusion is that the acl top 550 cts was performing as intended.Based on the above, there was no indication of an instrument malfunction and no remedial action is needed.
Event or Problem Description
A customer reported that their acl top 550 cts generated erroneous aptt results using hemosil synthasil.Three patients were administered an increased dose of heparin based on the erroneous aptt results.The aptt results were later corrected and the heparin doses were adjusted as appropriate.After the additional dose of heparin, the patients were monitored and there were no complications from the additional heparin administered.

• Brand Name: ACL TOP 550 CTS
• Common Device Name: INSTRUMENT, COAGULATION, AUTOMATED
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• MDR Report Key: 8383931
• Report Number: 1217183-2019-00003
• Device Sequence Number: 420657
• Product Code: GKP
• UDI-Device Identifier: 08426950729242
• UDI-Public: 08426950729242
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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
• Operator of Device: No Information
• Device Model Number: 2800-45
• Device Catalogue Number: 00000280045
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other