MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY ACL TOP 500 CTS; INSTRUMENT, COAGULATION, AUTOMATED, 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 08/11/2019

Event Type  Injury  

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 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
• Type of Device: INSTRUMENT, COAGULATION, AUTOMATED, 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: reba daoust ; 180 hartwell road; bedford, MA 01730 ; 7818614597
• MDR Report Key: 8956671
• MDR Text Key: 156392386
• Report Number: 1217183-2019-00004
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• 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: 08/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other