MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY ACL TOP 500 CTS

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	08/14/2017
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 were appropriately determined by the analyzer and the instrument was performing as intended.Note: a review of the instrument service report from the date of the incident indicates the customer's use of washed cuvettes on the instrument, which is not recommended.While the root case cannot be determined, there are many variables that have the potential to influence the result recoveries.These may include, but not limited to, the accuracy of the reconstitution of the reagents and cleaning materials used, the on-board stability of materials used, the use of washed cuvettes, reagent and/or sample handling, and sample integrity all of which could have contributed to the generated findings.Based on the above, there was no indication of an instrument malfunction and no remedial action is needed.
Event or Problem Description
Customer reported that their acl top 500 cts reported erroneous aptt patient results using hemosil synthasil.Of the 41 affected patient samples, fifteen to twenty patients were administered unnecessary boluses of heparin due to results being lower than expected.All forty-one samples were subsequently corrected and there were no reported serious adverse events.

• Brand Name: ACL TOP 500 CTS
• Common Device Name: ACL TOP
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• MDR Report Key: 6856196
• Report Number: 1217183-2017-00003
• Device Sequence Number: 820001
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/11/2017

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
• Was the Report Sent to FDA?: No
• Device Age: 6 YR
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 09/11/2017
• 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