MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA AUTOSLIDE SYSTEM

Model Number ADVIA AUTOSLIDE SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics inc.'s investigation determined that the advia 2120i with dual aspirate autosampler instrument did produce an error message immediately prior to the creation of the blood film slides by the advia autoslide system.Siemens healthcare diagnostics inc.Is investigating the cause of the two blood film slides being mislabeled on the advia autoslide system.

Event Description

Two blood film slides were mislabeled when created on the advia autoslide system.The morphology characteristics of the blood film slides labeled with sample identification (sid) numbers (b)(6) did not match the respective complete blood counts (cbc) produced by the advia 2120i with dual aspirate autosampler instrument.The morphology characteristics of the blood film slide sid (b)(6) matched the cbc for sid (b)(6) and the morphology characteristics of sid (b)(6) matched the cbc for sid (b)(6).No erroneous results were released to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the mislabeled slides produced by the advia autoslide system.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr (2432235-2016-00095) on february 26, 2016.June 6, 2016, additional information: siemens concluded their investigation into the cause of the two blood film slides being mislabeled on the advia autoslide system and could not confirm the complaint.The customer could not provide the glass slides that were produced by the advia autoslide system nor could they provide the necessary log files for the investigation.A siemens' field service engineer visited the customer site and did not find any issues with the advia autoslide system.The cause of the two blood film slides being mislabeled on the advia autoslide system is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA AUTOSLIDE SYSTEM
• Type of Device: ADVIA AUTOSLIDE SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): ABX, PARC EUROMEDICINE; registration no. 3000148879; rue du chaducee, bp 7290; montpellier, cedex 4, 34184 ; FR 34184
• Manufacturer Contact: elizabeth bernasconi ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242495
• MDR Report Key: 5463527
• MDR Text Key: 39210255
• Report Number: 2432235-2016-00095
• Device Sequence Number: 0
• Product Code: GKF
• Reporter Country Code: UK
• PMA/PMN Number: K051693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA AUTOSLIDE SYSTEM
• Device Catalogue Number: 10282177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1