MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY ACL TOP 500 CTS; INSTRUMENT, COAGULATION, AUTOMATED, 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	08/11/2019
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.Immediately following patient testing, aptt quality control failed.The aptt reagent vial was replaced and quality control results recovered within acceptable range.The patients in question were repeated and corrected aptt reports were generated.Based on the above, the acl top 500 cts system was performing within specification and no remedial action is needed.
Event or Problem Description
A customer reported that their acl top 500 cts generated erroneous aptt results using hemosil synthasil.Four patients had results that were clinically significant and needed to be corrected.One patient was administered an increased dose of heparin based on the erroneous aptt result.The aptt result was later corrected and the heparin dose was adjusted as appropriate.There were no known complications to the patient from the additional heparin administered.

• Brand Name: ACL TOP 500 CTS
• Common Device Name: INSTRUMENT, COAGULATION, AUTOMATED, PRODUCT CODE: GKP
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• MDR Report Key: 8956671
• Report Number: 1217183-2019-00004
• Device Sequence Number: 2521089
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/03/2019

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: 2800-40
• Device Catalogue Number: 00000280040
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/03/2019
• 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