MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. DETERMINE HIV 1/2 AG/AB COMBO 25T; IVD FOR HIV 1/2 AG/AB

Catalog Number 7D2648

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

The required information to enable further investigation, such as the kit's lot number, was not available and therefore a root cause investigation was not performed.Notwithstanding the above, a review of complaints' trend reveal that all of the alere determine (b)(6) 1/2 ag/ab combo batches are performing according to label claims.In conclusion, abbott diagnostics (b)(4) was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

Event Description

The customer reported multiple (approximately 5) false positive results on patients at two associated facilities while using the alere determine(b)(6) 1/2 ag/ab combo kit.The customer did not provide information on whether the false result was antibody (ab), antigen (ag) or dual (ab/ag).The customer did not provide information on sample types tested.Information on confirmation testing was not provided.The customer reported these were labor & delivery patients (pregnant females).There is insufficient information to determine if a malfunction occurred.Information on patient treatment and outcome was not provided.Attempts to gain additional patient information were not successful.

• Brand Name: DETERMINE HIV 1/2 AG/AB COMBO 25T
• Type of Device: IVD FOR HIV 1/2 AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 12677313
• MDR Text Key: 282964842
• Report Number: 1221359-2021-03234
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP120037-0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1