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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The employee who experienced the needlestick was administered anti-viral medication based on the inconsistent (b)(6) results between methods for samples from the patient associated with the needlestick.No (b)(6) results were provided for the employee.The interpretation of results section of the instructions for use states: "specimens with an index value greater than or equal to 1.0 are considered initially (b)(6) for p24 antigen and/or antibodies to (b)(6) and/or (b)(6) and should be retested in duplicate.After centrifugation at 10,000 x g for 10 minutes.If one or both of the duplicates are (b)(6), the specimen is repeatedly (b)(6) by the (b)(6).Note inadequate centrifugation may result in a higher rate of repeat (b)(6) results that must be investigated using supplemental tests for (b)(6) and/or (b)(6) and/or p24 antigen.Repeatedly (b)(6) specimens must be investigated using supplemental tests for (b)(6) and/or (b)(6) and/or p24 antigen.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 antibodies and/or p24 antigen, appropriate counseling and medical evaluation should be offered and is considered an important part of testing for antibody to (b)(6) and (b)(6) and/or p24 antigen." the cause for the discordant (b)(6) results is unknown.Siemens received two samples from the customer.The samples were tested with (b)(6) lots 117180 and 117192.The samples were (b)(6) with both lots of reagents sid (b)(6), chiv lot 117180, 0.950 index; chiv lot 117192, 0.393 index.Sid (b)(6), chiv lot 117180, 0.923 index; chiv lot 117192, 0.491 index.Siemens did not reproduce the customer's results.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the false (b)(6) results, siemens cannot rule out pre-analytical factors such as inadequate centrifugation, or a sample specific issue.Siemens' service went on site and completed a total service call.The system was checked and qc was in range.No issues were found.No further investigation required.
Event or Problem Description
Customer reported that an employee is being administered anti-viral medication (pap med) as a result of a needlestick associated with a patient displaying inconsistent (b)(6) results between the advia centaur xp (b)(6) ag/ab combo (b)(6) assay and two alternate methods.There is no evidence that the employee who experienced the needlestick was tested for (b)(6).There is no indication of adverse health consequences due to the needlestick or the anti-viral medication.

• 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
• MDR Report Key: 8487270
• Report Number: 1219913-2019-00047
• Device Sequence Number: 2689696
• Product Code: MZF
• UDI-Device Identifier: 00630414589749
• UDI-Public: 00630414589749
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 10696880
• Device Lot Number: 23706180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1