MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK NOVUS PACKED

Catalog Number 10494134

Device Problem Accessory Incompatible (1004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint was raised to manufacturing who investigated the issue.Investigation concluded that this was an isolated incident caused by manual stacking of the cards during manufacturing.Due to this finding, manufacturing is ensuring that all cassettes that have not been automatically processed by the line will be checked by the visions system to ensure they are packaged correctly and an alert has been raised to ensure future cassettes are automatically processed.There have been no other complaints for this issue.

Event Description

The customer reported that in the box of the reagent cards (pro12) used on the novus, some were assembled in the opposite direction so that the test pads were read by the device in the incorrect order.The customer stated that they received incorrect protein results that were reported to the physician.The lab technician re-ran the samples and got correct results and a corrected report was issued.Siemens requested the results but they have not been provided.There was no report of injury due to this event.

• Brand Name: CLINITEK NOVUS PACKED
• Type of Device: NOVUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 7895822
• MDR Text Key: 120967122
• Report Number: 3002637618-2018-00109
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00630414981130
• UDI-Public: 00630414981130
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2018

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: Health Professional
• Device Catalogue Number: 10494134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: No
• 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