MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379675

Device Problem False Negative Result (1225)

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

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens engineer evaluated the instrument and did not find any hardware issues by running check cassette five times along with electronics and test table testing.The qc results were in the expected ranges.A successful correlation study was run with fresh positive and negative urine samples.The cause of this event is unknown.

Event Description

The customer reported a false negative and borderline urine hcg result from the clinitek status+ compared to a positive result from a home pregnancy test and from a non-siemens qualitative manual test kit.The customer stated that the patient is believed to be pregnant although there was no confirmatory serum test run.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury, CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: tim krauskopf ; 2 edgewater drive; norwood, MA 02062 ; 8622285388
• MDR Report Key: 8164902
• MDR Text Key: 130504482
• Report Number: 3002637618-2018-00135
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2018

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: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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