MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Model Number 10379675

Device Problem False Negative Result (1225)

Patient Problem Nausea (1970)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens has asked the customer if they are able to provide the patient sample, some test packs of lot # 075110 and if they are willing to send the instrument back for investigation.The customer has declined the requests.The customer stated they are operational.Without any product returned to investigate, or the customer's ability to reproduce the false negative situation again on lot 075110, the root cause can not be determined.The certificate of analysis for hcg lot 075110 was reviewed and it met all specifications prior to manufacturing release.An investigation will not be performed for this event.The customer stated that there is an indication of an operator technique problem because they have been seeing a lot of insufficient sample errors.

Event Description

The customer reported a false negative hcg result on the clinitek status+ when compared to repeat results on the same instrument and another clinitek status+ and the results of an ultrasound examination of the pelvis.There is 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: felix akinrinola ; 2 edgewater drive; norwood, MA 02062 ; 6107052212
• MDR Report Key: 11337546
• MDR Text Key: 232601437
• Report Number: 3002637618-2021-00007
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10379675
• Device Catalogue Number: 10379675
• Date Manufacturer Received: 01/29/2021
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 20 YR