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 False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

All available patient information has been included.No additional patient information is available.A second adverse patient event is being submitted against the same suspect medical device, in manufacturer report number 3002809144-2019-00351.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false reactive hiv ag/ab results for various samples that were repeat reactive, when processing on the architect i2000sr.The following cases were provided: sid (b)(4): initial result was 1.88 s/co and retest was 1.89 s/co for a (b)(6) year old female patient.The patient was scheduled to donate bone marrow to her younger brother, however due to the false reactive result the bone marrow donation was delayed and the donor has to return after a month and a half for a second sampling.Additional testing for this patient was: anti-hcv 0.10 s/co, havab m2 0.12 s/co, and anti-hbc ii 0.26 s/co.No additional impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of tracking and trending data, a review of the performance of the likely cause, testing using a retained reagent kit of the complaint lot, and a review of product labeling.Ticket searches determined that there is slightly elevated complaint activity for the likely cause lots, but most complaints were for false reactive results.The tracking and trending report did not identify any trends for the complaint issue.Worldwide field data was used to review the overall performance of architect hiv ag/ab combo reagents and determined the values for the complaint lot are within their established limits and comparable to the values of other architect hiv ag/ab combo reagent lot numbers.The field data showed that reagent performance regarding specificity is acceptable.A retained reagent kit of the complaint lot was tested in a specificity setup.Results of this setup did not implicate that the specificity performance of the lot is negatively impacted.The reagent kit showed normal performance without false reactive results.No nonconformances, potential non-conformances or deviations were identified.A systemic issue was not identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.A second patient event is being submitted against the same suspect medical device, in manufacturer report number 3002809144-2019-00351.

• 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
• MDR Report Key: 8730595
• MDR Text Key: 149069975
• Report Number: 3002809144-2019-00352
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2019
• Device Catalogue Number: 04J27-27
• Device Lot Number: 96253LI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02; ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4); SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-02; SERIAL: (B)(4)
• Patient Outcome(s): Other