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

Catalog Number 10379675

Device Problem False Negative Result (1225)

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

Event Date 01/14/2014

Event Type  Other  

Event Description

Customer reported that a urine human chorionic gonadotropin (hcg) result reported as negative on the instrument.Customer reported that the patient was in the emergency room and the doctor admitted the patient to the operating room and ordered the hcg.The initial result was negative and the doctor questioned the result.A serum hcg was ordered and it was positive.Customer indicated they repeated the test and the hcg was positive.There was no report of injury due to this event.

Manufacturer Narrative

The cause for the discordant urine hcg result is unknown.Siemens technical operations team requested the sample for investigation.

• 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 road; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steve andberg ; 2 edgewater dr.; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3641800
• MDR Text Key: 4348021
• Report Number: 1217157-2014-00012
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• 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
• Date Manufacturer Received: 01/14/2014
• 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