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

Catalog Number 10379678

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued.Siemens has requested the reagent to be sent back for investigation.The cause of this event is unknown.

Event Description

The customer reported a false negative urine hcg result on the clinitek status and a positive serum result on a non-siemens lab analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens evaluated the submitted reagent which showed no obvious signs of damage or degradation; individual cassette foil packages were properly sealed, containing the expected desiccant & micropipette.No patient sample or instrument was provided.Performance of the submitted cassettes was evaluated on two clinitek status+ instruments using a urine solution contrived to a 25 miu/ml hcg target, which is the concentration listed in the customer insert as being minimum for a positive determination, and a pooled negative urine.Six replicate test values were collected on each urine.Based on the data collected, the customer report of false negative hcg performance from clinitest hcg when tested on a clinitek status+ instrument was not observed.The root cause for the discordant results is unknown.

• Brand Name: CLINITEK STATUS+ FRANCE
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7418514
• MDR Text Key: 105438081
• Report Number: 3002637618-2018-00043
• Device Sequence Number: 1
• Product Code: JIL
• 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: 07/19/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10379678
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR