MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379679

Device Problem False Negative Result (1225)

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

Event Date 02/17/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture.Siemens has requested that the reagent be returned for investigation and the customer has agreed.There were no issues with technique or maintenance found.The cause of this event is unknown.

Event Description

The customer reported false negative leukocyte results on several patients on the clinitek status+ compared to the microscopic examination of the sediment.There was no report of injury due to this event.

Manufacturer Narrative

Updated contact office - name/address.Siemens tech ops has completed the investigation: the customer supplied the reagent - multistix 10 sg (7 strips), but no patient samples were received.The strips were visually inspected for abnormalities, none were found.The dessicant was in the bottle as it should be.Using the customers strips, they were dipped into leukocyte esterase release solution - 10 cells/dl and run on the status+.Seven trace leukocyte results were obtained.There were no false negative results observed.The cause of the event is unknown.Per the customer bulletin "causes of leukocyte discrepancies between reagent strip and microscopic method", the cell membranes of leukocytes tend to lyse more readily in urines with lower specific gravity (hypotonic), but they remain intact for longer periods in urines with higher specific gravity (hypertonic).Since the reagent strip reacts with the leukocyte elastase (an esterase) contained within the cell, it is necessary for some of the cells to have lysed in order to be detected with the reagent strip.Therefore, urine samples with higher specific gravities tend to have fewer lysed cells, which would produce fewer positive reagent strip results.Microscopically, the intact leukocytes would still be visible.The cause of the event is unknown.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8475522
• MDR Text Key: 140679735
• Report Number: 3002637618-2019-00038
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

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: Health Professional
• Device Catalogue Number: 10379679
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1