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

Catalog Number 10379675

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2014

Event Type  No Answer Provided  

Event Description

Customer reported false negative human chorionic gonadotropin (hcg) result on the instrument.There was no report of injury due to this event.

Manufacturer Narrative

The cause for the discordant false negative human chorionic gonadotropin (hcg) result is unknown.

Manufacturer Narrative

As per siemens investigation data, two cassettes were run with the patient's urine and obtained negative results.The urine and serum were sent out for immulite testing in siemens la.The results came back negative for urine (6.61 miu) and positive for serum (79.08 miu).With this small hcg negative concentration in urine, a faint line might appear which we saw, but was not as dark as the 25 miu reference line resulting in a negative result.The siemens immulite is validated for urine and detects the most variants of all immunochemistry analyzers.The urine immulite results match the negative results the customers clinitek status instrument reported.The immulite also matched the serum results obtained from the customer which was positive (79.08 miu immulite and 64 miu siemens dimension).It appears there was possibly heterophilic antibodies that were in the serum that were not in the urine.A reference regarding heterophilic antibodies whereby the serum can give false positive rests was published stating: a urine test (either quantitative or qualitative) for hcg can be performed.Because heterophilic antibodies are not present in urine, if the urine test result is negative and the serum test result is persistently positive, interference in the serum immunoassay is confirmed if the serum value is >=50 miu/ml (3).Reference: rotmensch s, cole la.False diagnosis and needless therapy of presumed malignant disease in women with false-positive human chorionic gonadotropin concentrations.Lancet 2000;355:712-5.

• 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: 4223342
• MDR Text Key: 20298801
• Report Number: 1217157-2014-00167
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2014

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: Other
• Device Catalogue Number: 10379675
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1