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

Catalog Number 10332185

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2014

Event Type  malfunction  

Event Description

Customer reported the misidentification of multistix 10 sg as multistix pro 10 lb on the instrument with pyridium sample.There was no report of injury for this event.

Manufacturer Narrative

Customer stated the patient results were reported to the physician and results were questioned.Customer has been informed not to run abnormally colored urine samples on instrument particularly pyruvate/pyridium samples.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 received and installed software version 2.5 which will trigger and error code (e50) instead of a misidentification.Instrument is operational.

Manufacturer Narrative

Customer was previously using software version 1.8, which they have received and installed software version 2.4 which will trigger error code (e50) instead of a misidentification.

Manufacturer Narrative

Correction to mfr report #: incorrect: 1217157-2017-00102.Correct: 1217157-2014-00102.

• 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; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3961894
• MDR Text Key: 21526614
• Report Number: 1217157-2014-00102
• 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: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: 08/11/2014; 08/11/2014
• Supplement Dates FDA Received: 08/13/2014; 10/15/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1