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 06/26/2023

Event Type  malfunction  

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 two (2) of three (3).The customer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on an unknown date using an unknown sample type.Confirmation testing via unknown platform 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.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.

Manufacturer Narrative

B3 (event date): the date provided is an estimate as the exact date of occurrence was not provided.D4 (udi): (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 236039 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for kit part number 7d2648/ lot 236039 and device part number 10732998/ lot 234591.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 236039 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.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 and (b)(6) 2023.This mfr.Report addresses test two (2) of three (3).The customer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on an unknown date using an unknown sample type.Confirmation testing via unknown platform was performed using an unknown sample type and generated a negative result.No additional patient information, including treatment and outcome, was provided.

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 two (2) of three (3).The customer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on an unknown date using an unknown sample type.Confirmation testing via unknown platform 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).These two (2) events were previously reported out of caution as there was no patient information available at the time of the initial report.As the two (2) patients are males, these two (2) events are not reportable as the false positive result(s) does not represent a risk to the patient that has or could result in a death or serious injury.G3 (date received by mfg): the date provided on the initial report (26jun2023) should have been reported as 28jun2023.H3 other text : single use; device discarded.

• 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: 17300029
• MDR Text Key: 319420501
• Report Number: 1221359-2023-01269
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Device Lot Number: 236039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/11/2023; 08/16/2023
• Supplement Dates FDA Received: 08/04/2023; 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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
• Patient Age: 31 YR
• Patient Sex: Male