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

Catalog Number 04J27-27

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

The customer stated that the architect analyzer generated (b)(6) results on one patient samples.The results provided were: initial (b)(6) 2014 = 0.84s/co (<1.00 s/co = (b)(6)) / repeat testing = 15.54s/co (>/= 1.00s//co = (b)(6)).There was no reported impact to patient management.There was no additional patient information provided.

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Further evaluation of the customer issue included a review of the complaint text, a review for similar complaints, sensitivity testing, a review of manufacturing records, and a review of labeling.The customer observed (b)(6) results when using architect hiv ag/ab combo reagent, list number 4j27-27, lot number 35779li00.The customer obtained results of (b)(6) when testing a patient sample with the architect hiv combo assay.The controls were not within specification when these results were generated.Viral load testing of the sample gave a (b)(6) result.A new sample of the patient generated a clear non-reactive result.No returns were available for investigation.A review of manufacturing records did not reveal any events or issues that may have impacted the performance of lot 35779li00 in relation to the complaint issue.A review of complaint records for lot 35779li00 did not identify any problems relating to sensitivity or specificity.A retained kit of architect hiv ag/ab combo reagent, lot number 35779li00 was tested and all control values met control specifications.The sensitivity of lot 35779li00 was evaluated by testing two commercially available seroconversion panels.The architect reagent detected the same bleeds as reactive for the seroconversion panels.Based on this data it was shown that the sensitivity performance is acceptable.A review of product labeling concluded that potential false non-reactive, potential false reactive results and controls out of range are sufficiently addressed.All reactive results should be handled according to package insert.Furthermore, the architect hiv ag/ab combo control values must be within the acceptable ranges specified in the control package insert.If a control is out of its specified range, the associated test results are invalid and must be retested.There is not enough information to reasonably suggest a malfunction.Based on the investigation, it has been determined that the architect hiv ag/ab combo reagent lot 35779li00 is performing acceptably.

• 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: 3833299
• MDR Text Key: 4504457
• Report Number: 3002809144-2014-00130
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 05/08/2014

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: Health Professional
• Device Expiration Date: 09/13/2014
• Device Catalogue Number: 04J27-27
• Device Lot Number: 35779LI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 05/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)