MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK ADVANTUS

Catalog Number 10484765

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2021

Event Type  malfunction  

Manufacturer Narrative

The customer stated that visual microscopy of the sample showed it to be highly turbid with a lot of neutrophils and bacteria.The customer did not provide the results of the other analytes on the strip however, based on their description the sample likely had a high specific gravity.Per siemens customer facing documentation, "it has been observed that higher urine specific gravity may sometimes cause decreased leukocyte test results".Siemens has requested additional information however the customer has not responded.

Event Description

The customer reported a false negative leukocyte result from their clinitek advantus instrument compared to repeat testing by visual microscopy.There is no report of injury due to this event.

Manufacturer Narrative

The customer stated that the reagent is not available for return for investigation.Siemens has reviewed the certificate of analysis of the lot in question.The lot was meeting specifications at the time of manufacturing release.The customer is operational.The cause of this event is unknown.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): KIMBALL ELECTRONICS; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne, 62080 ; PL 62080
• Manufacturer Contact: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 13295433
• MDR Text Key: 288686947
• Report Number: 3002637618-2022-00006
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

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: 10484765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/08/2022
• 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
• Patient Age: 92 YR
• Patient Sex: Male