MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS; CT STATUS

Catalog Number 10332185

Device Problem False Reading From Device Non-Compliance (1228)

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

Event Date 03/07/2014

Event Type  malfunction  

Event Description

Customer reported that a multistix 10sg dipstick read erroneously as a multistix pro 10ls dipstick on the instrument.Customer indicated that patient was not treated based on that results.There was no report of injury for this event.

Manufacturer Narrative

Customer indicated that they were testing a patient sample that most likely containing a color interferant hence the red-orange color.Customer has been informed that running abnormally colored urine on the instrument is not recommended and they should instead send those samples to a reference lab.As per reagent ifu: substances that cause abnormal urine color may affect the readability of test pads on urinalysis reagent strips.These substances include visible levels of blood or bilirubin and drugs containing dyes (e.G., pyridium, azo gantrisin, azo gantanol), nitrofurantoin (macrodantin, furadantin), or riboflavin.Customer has also been offered upgraded software which will flag strip(e50) error.Customer must make sure that they are following the proper dipping / testing technique especially paying close attention to the dragging the strip edge along the top of the sample container to remove as much of the excess fluid from the strip as possible.Instrument is performing as intended.

• Brand Name: CLINITEK STATUS
• Type of Device: CT STATUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road,; chilton industry; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3698807
• MDR Text Key: 20322895
• Report Number: 1217157-2014-00045
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2014

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: Other Health Care Professional
• Device Catalogue Number: 10332185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1