MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HIV AG/AB COMBO; HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES

Model Number	2P36-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No specific patient information was provided.
Event or Problem Description
The customer obtained a (b)(6) architect hiv ag/ab combo result for a known (b)(6) sample.The sample was retested and generated (b)(6) results.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.The reagent lot was obtained from the customer and lot number was changed from unknown to 07190be00.
Additional Manufacturer Narrative
Review of complaint activity associated with reagent lot 07180be00 identified no other complaints related to the complaint issue.Review of tracking and trending reports did not identify any related trends for the architect hiv ag/ab combo assay.A retained reagent kit of lot number 07190be00 was tested in a sensitivity setup.Results of this setup did not implicate that the sensitivity performance of the lot was negatively impacted.The reagent kit showed normal performance without false non-reactive results.The controls gave reproduceable reslts with normal variance.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels.The seroconversion panel results were compared to architect hiv test results provided by the panel manufacturer.The lot detected the same bleeds as reactive.Based on this evaluation the sensitivity performance of the complaint lot was not adversely affected.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect hiv ag/ab combo assay was identified.

• Brand Name: ARCHITECT HIV AG/AB COMBO
• Common Device Name: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9559360
• Report Number: 3002809144-2020-00020
• Device Sequence Number: 11341492
• Product Code: MZF
• UDI-Device Identifier: 00380740003890
• UDI-Public: 00380740003890
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2020

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: 05/19/2020
• Device Model Number: 2P36-25
• Device Catalogue Number: 02P36-25
• Device Lot Number: 07190BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 02/27/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/22/2020; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR, LIST 03M74-02,; ARCHITECT I2000SR, LIST 03M74-02,; ARCHITECT I2000SR, LIST 03M74-02,; SERIAL (B)(6); SERIAL (B)(6); SERIAL (B)(6)