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 06/10/2014

Event Type  malfunction  

Event Description

The customer stated that negative architect hiv ag/ab results of (b)(6) were generated on a patient that was known to be (b)(6) for (b)(6).The patient was (b)(6) with (b)(6), and determine.Insti test was a questionable (b)(6).There was no report of impact to patient management.

Manufacturer Narrative

(no consequences or impact to patient); (false negative result).This report is being filed on an international product, list number 4j27 that has a similar product distributed in the us, list number 2p36.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Potential false negative architect hiv ag/ab results of (b)(6) were generated on a patient that was known to be (b)(6).The sample was (b)(6) with the genscreen assay and the immunochromatographic hiv-1/hiv-2 antibody tests vika and determine.Result of the immunochromatographic hiv-1/hiv-2 antibody test insti was questionable (b)(6).The customer provided data indicating that retesting of samples from the same patient since the year 1996 showed a shift down of result values.The samples from 1996, 2000, 2003, 2004, 2005 and 2006 were still (b)(6), but the sample from 2009 was (b)(6) with (b)(6) and the current sample tested ((b)(6) 2014) was (b)(6) with (b)(6).No returns were available for investigation.A retained reagent kit architect hiv ag/ab combo lot 37211li00 was tested in a sensitivity setup.Results of this testing did not implicate that the sensitivity performance of the lots is negatively impacted.The reagent kits showed normal performance without (b)(6) results.In addition, the clinical sensitivity of the complaint lot was evaluated by testing two commercially available seroconversion panels (zeptometrix hiv 9016 and hiv 9018).The seroconversion panel results were compared to architect hiv test results provided by zeptometrix.The reagent lot detected the same bleeds as (b)(6) for the seroconversion panels.Based on these data it was shown that the sensitivity performance of lot 37211li00 is not adversely affected.The customer provided results of hiv-2 specific western blot new lav blot ii for samples from 2003, 2013 and 2014.The blot results for all three samples was (b)(6), however a reduction of signal and thus of antibody concentration was seen from the sample of 2003 to the sample of 2013 and 2014.In addition information was received which indicated that the patient has received treatment since 2000.The shift down of architect hiv results that the customer observed in the patient samples since the year 2000, may have occurred since the concentration of the (b)(6) and the concentration of the (b)(6), which are detected by the architect hiv assay, may have decreased over the years (e.G.Through anti-viral treatment).There may not have been enough (b)(6) present in the samples of 2009 and 2014 to trigger a (b)(6) response from the architect hiv ag/ab combo assay.The discrepant results between the architect assay and the other assays, which gave (b)(6) results, may occur at the detection limit due to differences in assay design.This may be observed in very rare cases, but is likely to affect all immunoassay platforms without impacting the overall assay sensitivity or specificity.Customer complaint data was reviewed and no adverse trends were identified.A review for non-conformances and deviations associated with the reagent lot in question was performed.This review resulted in no occurrences that could be linked to the customer observation.The architect hiv ag/ab combo reagent package insert was reviewed and was found to adequately address the issue.The studies referenced in the package insert of the architect hiv ag/ab combo assay demonstrated an excellent sensitivity performance of the assay.The seroconversion sensitivity of the architect hiv ag/ab combo assay was further evaluated within this evaluation by testing of the reagent lot with commercially available seroconversion panels confirming high sensitivity of architect hiv ag/ab combo assay in detection of early phase of hiv infection during the shelf life of the reagent.Furthermore, the architect hiv ag/ab combo assay has been designed to detect hiv infected patients as early as possible during initial infection, which it has shown since earlier samples created a reactive result with the assay.Generally monitoring of hiv patients is performed by regular monitoring of hiv-1 rna and cd4 t-cell count.The investigation did not identify a deficiency.

• 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: 3903020
• MDR Text Key: 4544018
• Report Number: 3002809144-2014-00148
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2014

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: Health Professional
• Device Expiration Date: 11/16/2014
• Device Catalogue Number: 04J27-22
• Device Lot Number: 37211LI00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 06/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN (B)(4); ARCHITECT I2000SR ANALYZER 3M74-02; ARCHITECT I2000SR ANALYZER 3M74-02; SN (B)(4)