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

Catalog Number 04J27-22

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

The account questioned nonreactive architect hiv ag/ab combo results of (b)(6) on a patient sample (id (b)(6)) that tested roche modular hiv combo (b)(6) of (b)(6).Western blot testing was negative for all bands.Additionally, the patient has no clinical history and tested roche modular hbsag nonreactive.No impact to patient management was reported.

Manufacturer Narrative

The complete patient identifier is (b)(6).This report is being filed on an international product, architect hiv ag/ab combo list 04j27, that has a similar us product distributed in the us, architect hiv ag/ab combo list 02p36.No consequences or impact to patient.False negative result.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Evaluation in process.

Manufacturer Narrative

No customer returns were received for evaluation.A review of the product labeling concluded that the issue is sufficiently addressed.A retained kit of architect (b)(6) reagent lot number 33296li00 was tested and all control values met control specifications and were in the typical range.In addition, the clinical sensitivity of the affected lot was evaluated by testing two commercially available seroconversion panels.The reagent detected the same bleeds as reactive for the seroconversion panels.Based on this data it was shown that the sensitivity performance is not adversely affected.Ticket searches determined that there is no atypical complaint activity for the likely cause lot.The tracking and trending report review determined that there are no related adverse trends and no non-statistical trends identified for the complaint issue.All together, based on this evaluation, the product is performing as intended and no product issues were identified.

• 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 ; 847937-512
• MDR Report Key: 3782163
• MDR Text Key: 18298959
• Report Number: 3002809144-2014-00125
• 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,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2014

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
• Device Operator: Other
• Device Expiration Date: 07/18/2014
• Device Catalogue Number: 04J27-22
• Device Lot Number: 33296LI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 04/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• 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: 17 YR