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 False Negative Result (1225)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

The customer observed clear (b)(6) results when testing three samples from the same patient ((b)(4)) with (b)(6).The samples resulted (b)(6) and were also (b)(6) on western blot.Two of the samples gave also (b)(6) results when retested after they were frozen, but the third sample resulted (b)(6) with 2.32 s/co.After dilution of the samples they resulted (b)(6).These dilutions were also tested with the roche modular (b)(6) and gave higher results than the undiluted sample.No impact to patient management was reported.

Manufacturer Narrative

(b)(4).Additional information indicated that the affected samples were not treated according to package insert recommendations as the shipping process takes up to 4 weeks.According to the package insert the samples can be stored for max.Fourteen days on the clot at 2-8 degrees-c.Furthermore, although the samples were turbid, they were not centrifuged at 10000 rcf as required per package insert.The retesting was performed with thawed sample material, which was also not centrifuged at 10000 rcf as required per package insert.A retained kit of reagent lot 41259li00, which contains identical bulk reagent as lot 41260li00, was tested in a sensitivity setup.Results of this setup did not implicate that the sensitivity performance of the lot is negatively impacted.The reagent kit showed normal performance without (b)(6) results.The clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels.The lot detected the same bleeds as reactive for the seroconversion panels.Based on these data it was shown that the sensitivity performance of the complaint lot is not adversely affected.Ticket searches determined that there is normal complaint activity for the likely cause lot and the tracking and trending report review determined that there are no related adverse trends and no non-statistical trends identified for the complaint issue.Review of the product labeling concluded that the issue is sufficiently addressed in the assay package insert.Based on the investigation results, no product deficiency was identified to be related to this issue.

Manufacturer Narrative

Both patient samples ((b)(6)) were returned for investigation.The returned samples were tested with a retained kit of lot 41260li00 and (b)(6) results were obtained from both samples.The customer observation was then not repeated.The new information did not change the previous conclusion of no malfunction identified.

Manufacturer Narrative

Product evaluation was re-performed to conclude no malfunction and no product deficiency were identified.The issue was attributed to sample integrity, handling and processing factors.

• 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 6520 5; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 4297603
• MDR Text Key: 5270209
• Report Number: 3002809144-2014-00197
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2015
• Device Catalogue Number: 04J27-32
• Device Lot Number: 41260LI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000 ANALYZER, LN 03M74-01; ARCHITECT I2000 ANALYZERS, LN 03M74-01; ARCHITECT I2000 ANALYZER, LN 03M74-0; ARCHITECT I2000 ANALYZER, LN 03M74-0; SN (B)(4); (B)(4); (B)(4); (B)(4)