MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE LIS; CALCULATOR/DATA PROCESSING MODULE

Model Number 3.9.3

Device Problem Data Problem (3196)

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

Event Date 12/02/2014

Event Type  malfunction  

Manufacturer Narrative

Upon retrospective review, the issue was determined to be reportable as an mdr.

Event Description

Under rare circumstances, customers are sometimes finding that samples from different patients are assigned the same container number.When you bring up the sample in order entry by container id, the system displays two patients.When the instrument returns the result to lis, lis will use the container id to try to find the patient record.Lis then assigns the result to the "first patient that system finds" that matched to the container id.Lis is not expecting duplicate container ids and may document the results for one patient in the record for another patient.

• Brand Name: MERGE LIS
• Type of Device: CALCULATOR/DATA PROCESSING MODULE
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge rd; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5331353
• MDR Text Key: 34524326
• Report Number: 2183926-2015-00006
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE- EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3.9.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2183926-01/04/2016-026-C
• Patient Sequence Number: 1