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

Catalog Number 7D2648

Device Problem False Positive Result (1227)

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

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

B3 (event date): the date provided is an estimate as the exact date of occurrence was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single use; device discarded.

Event Description

The customer reported three (3) false positive results with the determine hiv 1/2 ag/ab combo for multiple patients and tests performed on various unconfirmed dates between (b)(6) 2023.This mfr.Report addresses test one (1) of three (3).The customer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on an unknown date during the week of (b)(6) 2023 on an unknown sample type.Confirmation testing was not reported to have been performed.

Manufacturer Narrative

B3 (event date): the date provided is an estimate as the exact date of occurrence was not provided.The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.Single use; device discarded.

Event Description

The customer reported three (3) false positive results with the determine hiv 1/2 ag/ab combo for multiple patients and tests performed on various unconfirmed dates between (b)(6) 2023 and (b)(6) 2023.This mfr.Report addresses test one (1) of three (3).The customer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on an unknown date during the week of (b)(6) 2023 on an unknown sample type.Confirmation testing using hiv multispot was performed using an unknown sample type and generated a negative result.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

B3 (event date): the date provided is an estimate as the exact date of occurrence was not provided.Additional information received clarified that two (2) of the three (3) patients are males (reference mfr.Reports 1221359-2023-01269 and 1221359-2023-01270).The remainder of the investigation remains in progress.A supplemental will be provided upon completion or receipt of new information.B5 (event description) h3 other text : single use; device discarded.

Event Description

The customer reported three (3) false positive results with the determine hiv 1/2 ag/ab combo for multiple patients and tests performed on various unconfirmed dates between 19jun2023 and 28jun2023.This mfr.Report addresses test one (1) of three (3).The customer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on an unknown date during the week of 19jun2023 on an unknown sample type.Confirmation testing using hiv multispot was performed using an unknown sample type and generated a negative result.No additional patient information, including treatment and outcome, was provided.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 17300027
• MDR Text Key: 318931179
• Report Number: 1221359-2023-01268
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 00811877011101
• UDI-Public: 00811877011101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP120037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1