MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HIV AG/AB COMBO REAGENT KIT; TEST, HIV DETECTION

Catalog Number 04J27-78

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party? no.No patient identifier or additional demographic information is available.A review of tickets was performed for reagent lot number 23366be01.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect hiv ag/ab combo reagent lot number 23366be01 was identified.

Event Description

The customer generated a (b)(6) repeat reactive architect hiv ag/ab result for one patient.The following information was provided: (b)(6) 2021 initial result (b)(6) repeat after high-speed centrifugation (b)(6).Repeat with xiamen boson colloidal gold assay (b)(6).Repeat at another lab (b)(6).The patient is an (b)(6) year old man and was being hospitalized at the time of testing with the department of cardiology with coronary heart disease.No impact to patient management was reported.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: ARCHITECT HIV AG/AB COMBO REAGENT KIT
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11796060
• MDR Text Key: 268374721
• Report Number: 3002809144-2021-00300
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: 04J27-78
• Device Lot Number: 23366BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)
• Patient Age: 83 YR