MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. ACL TOP 300 CTS; COAGULATION ANALYZER

Model Number 2800-60

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2015

Event Type  malfunction  

Event Description

Customer reported receiving two erroneous aptt-ss results on two different patients on their acl top 300 cts instrument with hemosil synthasil aptt reagent.Per the customer, their morning qc passed, but the second shift failed.All patient samples tested between those two time periods were repeated after placing fresh reagent on board the instrument and obtaining control values in range at 15:30.The results obtained at that point correlated with the values obtained before the failed qc with the exception of the two aptt results referenced above.Both patients were treated with heparin based on the original results.The physician was alerted and further testing performed to ensure patients were back in therapeutic range.The customer confirmed no impact on the treated patients.

Manufacturer Narrative

Recovery of qc in range at 15:30pm, after replacing new aptt reagents, suggest that this incident was associated with contaminated aptt reagents.Due to many unknown factors of reagent handling on site and this being the only incident reported of this occurrence, qa eval associates this as an isolated random error most likely due to reagent handling.Based on this analysis no remedial action is required.

• Brand Name: ACL TOP 300 CTS
• Type of Device: COAGULATION ANALYZER
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; bedford MA
• Manufacturer Contact: carol marble ; 180 hartwell road; bedford, MA 01730 ; 7818614467
• MDR Report Key: 4828342
• MDR Text Key: 5911633
• Report Number: 1217183-2015-00001
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2800-60
• Device Catalogue Number: 00000280060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1