MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379676

Device Problem Non Reproducible Results (4029)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

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.The instrument has been requested for return to the workshop for investigation.Proper technique and maintenance were reviewed with the customer.There were no issues found.The cause of this event is unknown.

Event Description

The customer reported the clinitek status+ was generating borderline hcg results on negative samples.One patient's procedure (unknown) was delayed.

Manufacturer Narrative

Correction: changed product code - product code from jil to jhi (used for hcg).Siemens service report: all tests were performed using the power supply that came in with the instrument and the instrument was connected to its connect platform with the barcode reader plugged in.When service unpacked the table assembly, they noticed a mark on the calibration bar which looked like dry spillage.On closer inspection when the marks would not clean off, they found that the marks were physical damage to the bar.The table assembly was replaced and ten cassettes were run with no false results.

• Brand Name: CLINITEK STATUS+
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9214371
• MDR Text Key: 164915903
• Report Number: 3002637618-2019-00112
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10379676
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1