MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+ UK

Catalog Number 10379676

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 03/05/2020

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.Proper maintenance was reviewed with the customer and no issues were found.The calibration bar was clean and the qc passed.The device has been sent to siemens workshop for investigation and repair.Siemens has asked for the workshop report to be provided.The customer stated there was no harm to the patient.The cause of this event is unknown.

Event Description

The customer reported a false negative urine hcg on the clinitek status+.They repeated the urine test using a new sample and the result was positive.The hcg quantitative blood test was also positive.The customer stated that a grommet insertion - tube to prevent persistent fluid build up in the ear, was withheld.There was no report of injury due to this event.

Manufacturer Narrative

Siemens has received the service report.The instrument was received with a damaged test table and the calibration bar was noticed to be dirty.The calibration bar was cleaned and the instrument was run on the ate and failed with a clean calstrip error.An inspection of the internal mirror found some splash marks on it.The mirror was cleaned and the instrument then passed the ate tests.The damaged test table was replaced.The customer stated that they were operational.

• Brand Name: CLINITEK STATUS+ UK
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9879246
• MDR Text Key: 187099134
• Report Number: 3002637618-2020-00013
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1