MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC CLINITEK STATUS+ ANALYZER

Catalog Number 10379677

Device Problems False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2014

Event Type  Other  

Event Description

Customer reported that a multistix 7 dipstick read erroneously as a labstix sg dipstick on the instrument.Customer reported that the instrument does not print the results for leukocyte and nitrite, but instead they get results for sg.This was observed twice right after each other, same pt, but they reported that they have seen this issue two other times before.There was no report of injury for this event.

Manufacturer Narrative

The cause for multistix 7 being misidentified as labstix sg is due to incorrect sample technique.Customer needs to make sure that they are following the correct testing technique by pressing the start button, dipping the strip, dragging the edge of the test strip along the edge of the sample container and also blotting the edge of the test strip before placing onto the test table.This will aide in the removal of as much excess sample from the id band on the test strip and decrease the likelihood of misidentifications.The instrument is performing as intended.

• Brand Name: CLINITEK STATUS+ ANALYZER
• Type of Device: CLINITEK STATUS+ ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; northern rd; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steve andberg ; 2 edgewater dr.; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3704396
• MDR Text Key: 4234636
• Report Number: 1217157-2014-00036
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/17/2014

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: Health Professional
• Device Catalogue Number: 10379677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1