MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS CLINITEK STATUS+; CT STATUS+

Catalog Number 10379676

Device Problem False Negative Result (1225)

Patient Problem Distress (2329)

Event Date 06/19/2014

Event Type  malfunction  

Event Description

Customer reported false negative human chorionic gonadotropin (hcg) result on the instrument.Customer indicated that patient was very distressed.There was no report of injury due to this event.

Manufacturer Narrative

Siemens technical operation team checked the instrument and found a full strip inside the instrument.They also found a piece of tissue, a piece of paper, and a pad stuck to the instrument case under the table center.There were also splash marks along the mirror.Siemens technical operation team removed all the debris and cleaned the mirror.Siemens technical operations team performed all service tests on the instrument and it passed all the tests.They also indicated several hcg samples were ran on instrument with no issue.From the investigation, it was determined that root cause for the false negative human chorionic gonadotropin (hcg) result is due to debris inside of the instrument and splash marks on the mirror.Instrument is operational.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industrial estate; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3932336
• MDR Text Key: 4578464
• Report Number: 1217157-2014-00101
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/20/2014

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: Other Health Care Professional
• Device Catalogue Number: 10379676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 07/14/2014
• 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
• Patient Age: 35