MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379675

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.Siemens reviewed cleaning and technique with the customer.Siemens has made three attempts to reach the customer to obtain additional information and to request the reagent cartridges back for investigation.There has been no response from the customer.The cause of this event is unknown.I am filing this mdr at fda's request.The original mdr (3002637618-2019-00123) was filed under procode jil.Per the fda, the device (k091216) has multiple product codes including jil, therefore using this procode is not incorrect.They are recommending that this mdr should also be filed under jhi (hcg) so that the mdr reviewer with the appropriate expertise receives it as well.

Event Description

The customer reported a false negative urine hcg result.An iud was then implanted in the patient.The patient later took a home pregnancy test and received a positive result.An ultrasound then showed the patient to be 6.5 weeks pregnant and the iud was removed.

• 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: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 9396030
• MDR Text Key: 169087793
• Report Number: 3002637618-2019-00126
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414574639
• UDI-Public: 00630414574639
• 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,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• 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?: No
• Date Manufacturer Received: 10/31/2019
• 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: Unknown
• Patient Sequence Number: 1