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

Catalog Number 02P36-25

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

The account generated a (b)(6) architect (b)(4) ag/ab combo result of (b)(6) on a patient sample that tested (b)(6) and (b)(4) western blot indeterminate.No additional patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

(b)(4).An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Manufacturer Narrative

Describe event or problem has been updated: "the patient sample tested (b)(6) western blot indeterminate with a single band at p18." this updated information was obtained from the completed evaluation.Manufacturing site of devices name and address has been updated.Upon review of the initial report the incorrect manufacturing site was inadvertently listed.No customer returns were available for evaluation.No further confirmation test results were provided by the customer.A retained kit of (b)(6) reagent in question was tested and all control values met control specifications and were in the typical range.The clinical (b)(6) was evaluated by testing two commercially available seroconversion panels.The reagent detected the same bleeds as reactive with comparable s/co values for the seroconversion panels.Based on these data it was shown that the sensitivity performance is not adversely affected.A review of labeling concluded that the issue is sufficiently addressed in the labeling.Ticket searches determined that there is no atypical complaint activity for the likely cause lot.The 12 month tracking and trending report review determined that there are no adverse trends and no non-statistical trends identified for the complaint issue.Based on this evaluation, it is concluded that the (b)(6) reagent lot 34441li00 is performing acceptably.

Event Description

The patient sample tested (b)(6) western blot indeterminate with a single band at p18.

• 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
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden IL 60064 350; GM 60064 3500
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3753957
• MDR Text Key: 15179978
• Report Number: 3002809144-2014-00119
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/08/2014
• Device Catalogue Number: 02P36-25
• Device Lot Number: 34441LI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-01; SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-01; SERIAL (B)(4)
• Patient Age: 54 YR