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

Model Number	2P36-35
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
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.There was no additional patient information provided by the customer.
Event or Problem Description
The customer reported false reactive architect (b)(6) ag/ab combo assay results for a (b)(6) year old male, who is currently taking the medication truvada.The patient does not describe any risk factors and tested negative for (b)(6) in (b)(6) 2019.The customer provided that on (b)(6) 2020 results for this patient were reactive with architect and via an alternate method.On (b)(6) 2020 sid (b)(6): initial = 38.30 s/co, repeats 58.45, 60.40 s/co.On (b)(6) 2020 the sample was tested on another method, geenius: initial testing result was (b)(6) indeterminate and (b)(6) nonreactive (gp41 present only).Repeat testing results were (b)(6) reactive and (b)(6) nonreactive (gp41 & gp160 present).On (b)(6) 2020 sid (b)(6) results = 0.22, 0.25, & 0.21 s/co.On (b)(6) 2020 (b)(6) initial = 0.22 s/co, repeats = 0.25, 0.21 s/co and sid (b)(6) initial = 54.68, repeat = 52.46 s/co.Architect (b)(6) ag/ab combo assay interpretation range: <1.00 s/co = nonreactive; => 1.00 s/co = reactive.There was no impact to patient management reported.
Additional Manufacturer Narrative
After further evaluation, the initial emdr was created and submitted in error.Suspect medical device 02p36-35 architect hiv ag/ab combo is not a screening assay in the united states and therefore not reportable.No impact to patient management was reported.Based upon this review, this complaint is no longer a reportable event and no further follow up will be provided.

• 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: 10446359
• Report Number: 3002809144-2020-00837
• Device Sequence Number: 3203108
• Product Code: MZF
• UDI-Device Identifier: 00380740003906
• UDI-Public: 00380740003906
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 08/31/2020

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: 10/03/2020
• Device Model Number: 2P36-35
• Device Catalogue Number: 02P36-35
• Device Lot Number: 12665BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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 ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02, SN (B)(4); LN 03M74-02, SN (B)(4)
• Patient Age: 32 YR