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

Catalog Number 04J27-32

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report is being filed on an international product, list number 04j27 that has a similar product distributed in the us, list number 02p36.The similar medical device in the us, architect hiv ag/ab combo, ln 02p36, is not intended for screening or transplant.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a (b)(6) architect hiv ag/ab result for a pregnant patient.(b)(6) treatment was unnecessarily administered to the newborn after delivery.The customer provided the following data: initial (b)(6).The specimen was retested using a confirmatory rapid test which generated a (b)(6) result.A viral load was also run and was (b)(6).The physician ordered administration of (b)(6) treatment to the newborn based on the initial result.There was no adverse impact reported due to the newborn patient having received (b)(6) therapy.

Manufacturer Narrative

Updates to (additional result data) and (lot number) were made.An investigation of the customer issue included a review of the complaint text, a field data review, a device history review, log review, a search for similar complaints, and a review of labeling.Return material was not available from the customer.An analysis utilizing field data was completed to determine if the median patient values have shifted over time.The analysis concluded that all reagent lots read patient results consistently therefore determined the reagent is performing acceptably.The device history review did not identify any non-conformances or deviations.A log review determined no conclusive information regarding the cause of the complaint issue could be identified.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect hiv ag/ab combo reagent, list number 4j27, lot number 79193li00, was identified.

Event Description

Additional result data was provided for the patient as follows: (b)(6).

• Brand Name: ARCHITECT HIV AG/AB COMBO
• Type of Device: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7071446
• MDR Text Key: 94301115
• Report Number: 3002809144-2017-00155
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2018
• Device Catalogue Number: 04J27-32
• Device Lot Number: 79193LI00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-02; ARCHITECT I2000SR ANALYZER, LN 03M74-02; SN (B)(4); SN (B)(4)
• Patient Outcome(s): Other