MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+

Catalog Number 10379676

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 09/06/2018

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 ifu for the clinitest hcg states: "recent studies suggest that urine hcg concentrations are approximately one-half of, or less than one-half, of corresponding serum hcg concentrations.Urine hormone levels greater than 25 miu/ml are reported as positive." a blood test result of 35 miuml would equate to about 17 miu/ml in urine and therefore would be below the detectable limit (25miu/ml) of the test.The workshop repair has been completed.The returned hcg cassettes were run and all results were as expected.The instrument failed the ate tests with a clean calstrip message and on inspection this was dirty so it was replaced.Ate tests were rerun and all passed with no errors.The customer is operational.

Event Description

The customer reported a false negative urine hcg result on the clinitek status+ compared to a positive blood test.There was 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: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 7907600
• MDR Text Key: 123964529
• Report Number: 3002637618-2018-00113
• 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,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/25/2018

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: Health Professional
• Device Catalogue Number: 10379676
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/25/2018
• 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