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

Catalog Number 10379676

Device Problem False Positive Result (1227)

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

Event Date 10/11/2014

Event Type  No Answer Provided  

Event Description

Customer reported 3 false positive human chorionic gonadotropin (hcg) results on the instrument.Customer indicated that serum human chorionic gonadotropin (hcg) results were negative for all 3 patient samples.

Manufacturer Narrative

The cause for the discordant false positive human chorionic gonadotropin (hcg) result is unknown.As per clinitest hcg pregnant test instruction for use, "the presence of heterophile antibodies or non-specific protein binding may cause false-positive results in sensitive immunoassays.If a qualitative interpretation is inconsistent with the clinical evidence, results should be confirmed by an alternative hcg detection method.".

Manufacturer Narrative

Siemens repair center inspected the instrument and found a reagent strip and a pad stuck to the serial cable.Siemens repair center removed both a strip and a pad, cleaned a small mark from the internal mirror and run the instrument on the ate software and everything passed with no errors highlighted.Siemens repair center indicated that they ran hcg tests with no problems.This event is occurred due to an operator error.For the clinitek status+ analyzer to perform as intended and to provide reliable test results, customer should clean/maintain instrument as instructed in clinitek status+ operator's guide.Instrument is operational.

• 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: 4226423
• MDR Text Key: 5065173
• Report Number: 1217157-2014-00169
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2014

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: 10379676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1