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

Catalog Number 10379676

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint preparer provided the following service report: siemens customer service engineer (cse) supplied a new table insert as that was missing.The instrument was on version 2.5 software and was run on its own power supply.Cse ran some hcg tests and all results were as expected with no false results.Cse then ran the instrument on the ate and it failed with clean calibration strip so he cleaned the calibration strip and it then passed all tests.Cse then ran the instrument on it's connect platform as the customer has sent this in as well and no false results reported.Customer has been recommended to use only di water on calibration bar.As per clinitest hcg instructions for use (ifu), "negative test results in patients suspected to be pregnant should be retested with a sample obtained 48-72 hours later, or by performing a quantitative assay." and as per 'limitation' section of ifu, "as is true with any diagnostic test, clinical diagnosis should not be based solely on a single test result.Clinical diagnosis should incorporate all clinical and laboratory data." instrument is operational.

Event Description

Customer reported 2 false negative hcg results on the analyzer.Patient was having monthly urine hcg testing for use alongside drug dosing.Customer indicated that monthly results from (b)(6) were reported all negative.Patient had appointment with general practitioner and was informed she was 11 weeks pregnant, extrapolating back this would have meant at her last pregnancy test on the status+, she was approx.(b)(6) pregnant.Complaint preparer stated that at the time of testing patient was (b)(6) pregnant.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS+
• Type of Device: CT STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 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: 5235417
• MDR Text Key: 31578220
• Report Number: 1217157-2015-00172
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K032563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2015

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: No Information
• Device Catalogue Number: 10379676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1