MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. CLINITEK STATUS; ANALYZER, HUMAN CHORIONIC GONADOTROPIN

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 03/18/2018

Event Type  malfunction  

Event Description

The clinitek urine analyzer used to check urine for point-of-care testing (poct) had a positive result.The serum test used to check had results of < 1 miu/ml.The urine test was repeated showing borderline results.Another machine used showed negative results.

• Brand Name: CLINITEK STATUS
• Type of Device: ANALYZER, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 2 edgewater drive; norwood MA 02062
• MDR Report Key: 7388068
• MDR Text Key: 104039850
• Report Number: 7388068
• Device Sequence Number: 1
• Product Code: JHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

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: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 17 YR
• Patient Weight: 53