MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TOTAL HCG (THCG)

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the non-reproducible advia centaur xp thcg result is unknown.Quality control and calibrator were acceptable at the time of the event.Given that the qc and calibration were acceptable, the issue is most likely with the sample itself.The sample may not have had sufficient time to clot before spinning or was not spun long enough which could lead to imprecision.The limitations section of the instructions for use states: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present).If an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory.Test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal nonpregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results - sometimes in consultation with other medical experts." thcg reagent lot was not provided, therefore a udi # is not available.

Event Description

Customer observed an elevated advia centaur xp total hcg (thcg) result that was not elevated upon repeat testing.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp thcg result.

Manufacturer Narrative

Siemens filed mdr 1219913-2016-00219 on november 22, 2016 reporting an elevated advia centaur xp total hcg (thcg) result that was not elevated upon repeat testing.The reagent lot number and udi were not available at the time of filing.November 30, 2016 additional information: advia centaur thcg reagnet lot 32869285, expiration date 03/17/2017, (b)(4).The customer also provided information that the patient is a smoker.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG (THCG)
• Type of Device: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 6122016
• MDR Text Key: 60868998
• Report Number: 1219913-2016-00219
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00643953
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 14 YR