MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDCOMM V4.0

Catalog Number 10379868

Device Problem Patient Data Problem (3197)

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

Event Date 12/25/2015

Event Type  No Answer Provided  

Event Description

Customer reported that erroneous result transferred from rapidcomm to lis (laboratory information system).Customer reported that sample log showed patient name as patient "a" but when they selected review the patient name, it came up as patient "b." there was no report of injury due to this event.

Manufacturer Narrative

Siemens representative had customer review the patient sample log and only one sample was found for sample time (b)(6) 2014 9:26 am on device rp500 (b)(4) which was patient "b." siemens representative also had customer link device to analyzer rp500 (b)(4) and found patient name was patient "a" and no symbol showed the device was edited.Customer will check both patients to verify who is (b)(6) and if entry made at the analyzer was manual or barcode.It appeared that operator made incorrect entry at analyzer and rapidcomm matched results to correct patient (patient b) and rapidcomm operator tried to edit sample in rapidcomm back to patient "a" and did a resend.This event is being investigated.The cause for the event is unknown.

Manufacturer Narrative

Based on the investigation report, the failure of samples with both names in the transfer log indicated that there was no order received during the matching period from the laboratory system.The existence of the same sample under two names indicated that the sample was transmitted once with the name matching the incorrect barcode number and once with the correct one.The customer was provided this information and the customer has confirmed that the issue is resolved.

• Brand Name: RAPIDCOMM V4.0
• Type of Device: RAPIDCOMM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS - ATLANTA; apc; 800 tradeport blvd; atlanta GA 30354
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4432479
• MDR Text Key: 15107117
• Report Number: 1217157-2015-00007
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10379868
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• Is the Device Single Use?: No
• Patient Sequence Number: 1