MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY; CHIV IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The (b)(6) patient result posted on a centralink from an advia (b)(6) instrument for (b)(6) after the first two results were (b)(6) on (b)(6) 2018.At the time that the customer reported this issue, the operator was concerned that centralink autovalidated the (b)(6) result.Upon investigation, it was found that the operator validated the (b)(6) result instead of following guidelines to revert to the first (b)(6) result for validation and upload.The operator has been instructed on how to handle this in the future.The advia (b)(6) ifu (10697136_en rev.D, 2017-12) states "repeatedly (b)(6) specimens must be investigated using supplemental tests for (b)(6).In specimens giving indeterminate supplemental test results, testing of a subsequent sample drawn at a later date (such as 1-6 months) is recommended.For individuals who are confirmed (b)(6) for (b)(6) and/or (b)(6), appropriate counseling and medical evaluation should be offered and is considered an important part of testing for (b)(6)." based on the information provided, the operator did not follow their guidelines.The instrument is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A patient sample was tested with advia (b)(6) assay three times.The results were (b)(6).The operator manually validated the third (b)(6) result that uploaded into centralink instead of following guidelines instructing to revert and release the first (b)(6) result.The (b)(6) result was not reported to the doctor.The error was caught before the result was sent to the doctor.Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant advia (b)(6) result.

• Brand Name: ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
• Common Device Name: CHIV IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7731359
• Report Number: 1219913-2018-00196
• Device Sequence Number: 19468193
• Product Code: MZF
• UDI-Device Identifier: 00630414589749
• UDI-Public: 00630414589749
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BP140103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2018
• Device Model Number: N/A
• Device Catalogue Number: 10696880
• Device Lot Number: 57675138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1