MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. 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	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident is currently under investigation with no malfunction identified to date.A follow-up report will be submitted when the complaint investigation is completed.
Event or Problem Description
Customer reported that their acl top 500 cts reported erroneous aptt results for 6 patients using hemosil synthasil.All 6 patient sample results were re-run and corrected.One patient (ch) was administered a bolus of heparin.Ch developed a superficial right groin hematoma.The customer was unable to determine if this was a result of the bolus of heparin.
Additional Manufacturer Narrative
Customer reported that their acl top 500 cts reported erroneous aptt patient results using hemosil synthasil.Six patient samples generated erroneous results.All six samples were subsequently corrected.One patient received a bolus of heparin.The patient developed a superficial right groin hematoma.The customer was unable to determine if this was a result of the bolus of heparin.Service was dispatched to the site to inspect the instrument.No visual problems were observed, all performance checks passed, and quality control was acceptable indicating that the instrument was performing as expected.A review of the submitted instrument backup was performed and data for the patient receiving the bolus of heparin could be found, however, the other results could not be located based on the identifiers provided.It can be determined that the patient sample generated a result of 58.6 seconds without errors or warnings and then generated results of greater than 200 seconds approximately two hours later.While the root cause cannot be determined, there are many variables that have the potential to influence the result recoveries.These may include but are not limited to, the on-board stability of the reagent and cleaning materials, sample collection and processing, instrument maintenance, and service, etc.

• Brand Name: ACL TOP 500 CTS
• Common Device Name: ACL TOP
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell rd; bedford MA 01730
• MDR Report Key: 7038808
• Report Number: 1217183-2017-00006
• Device Sequence Number: 1332025
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: Health Professional
• Device Model Number: 2800-40
• Device Catalogue Number: 00000280040
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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