MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. REF. H10

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 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant hav igm and hav total results is unknown.The calibration and the quality control for both assays were acceptable.Siemens healthcare diagnostics is awaiting further information.(b)(6)."the results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.A (b)(6) test result does not exclude the possibility of exposure to (b)(6) a virus.The advia centaur hav igm assay can be used to determine if a patient has or recently had an acute or asymptomatic hepatitis a infection.This test does not measure anti-hav igg and therefore cannot be used to determine a patient's immune status to (b)(6)." "the results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.A nonreactive test result does not exclude the possibility of exposure to (b)(6) a virus.".

Event Description

Discordant advia centaur xp hav igm (ahavm) and hav total (ahavt) results were obtained for a patient sample.The customer was concerned that a patient with symptoms for hepatitis a infection due to contaminated food had a (b)(6) result for ahavm and a reactive (b)(6) result for ahavt.The patient was not vaccinated for hepatitis a.The patient was tested again two weeks later for ahavm and ahavt on a redraw sample.The results were both (b)(6).The initial sample was sent out to be tested on an alternate method.The results for hep a igm and hep a igg were both (b)(6).Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant hav igm and hav total results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2016-00130 on august 02, 2016.On 08/16/2016 additional information: a siemens field service engineer (fse) was sent to the customer site.The instrument performance was tested.Only the acid pump and valve were replaced as a countermeasure.Alignment for probes 1,2, and 3 were performed.Dispense test for acid was performed.No issues were found.The patient sample is not available for further testing and investigation.The cause for the discordant hav igm and hav total results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: REF. H10
• Type of Device: REF. H10
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 5839636
• MDR Text Key: 51386692
• Report Number: 1219913-2016-00130
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: REF. H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• 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: REF. H10
• Device Lot Number: REF. H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• 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: 36 YR