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

Model Number	2800-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Therapeutic Response, Increased (2272)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A customer reported that their acl top 500 cts generated an erroneous aptt result (36.9 seconds) using hemosil synthasil.A patient was administered an increased dose of heparin based on this erroneous aptt result.Subsequently, another sample was drawn from the same patient (approximately 3 hours later) and it reported an aptt result of > 200.The heparin administration was stopped and the customer indicated that the patient's aptt result was brought back into the therapeutic range.There were no further reports of clinical implications for the patient.

• Brand Name: ACL TOP 500 CTS
• Common Device Name: ACL TOP, PRODUCT CODE: GKP
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• MDR Report Key: 8024101
• Report Number: 1217183-2018-00009
• Device Sequence Number: 16486164
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160276
• 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): 10/31/2018

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: 2800-40
• Device Catalogue Number: 00000280040
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/31/2018
• 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