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 Non Reproducible Results (4029)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : other - device not returned; single use device.

Event Description

The customer reported conflicting results within the read window using determine hiv 1/2 ag/ab combo performed on unknown dates using unknown sample types.The customer reported an unknown number of tests had a faint line at twenty (20) minutes and no line at thirty (30) minutes.Although requested, no additional information, including patient outcome or treatment, was provided.

Event Description

The customer reported conflicting results within the read window using determine hiv 1/2 ag/ab combo performed on unknown dates using unknown sample types.The customer reported an unknown number of tests had a faint line at twenty (20) minutes and no line at thirty (30) minutes.Although requested, no additional information, including patient outcome or treatment, was provided.

Manufacturer Narrative

D4: udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 784110 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 test kit part number 7d2648/lot 784110 , test base part number 10732998/lot 775153.The lot met the required release specifications.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 784110 showed that the complaint rate is (b)(4) respectively.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.H3 other text: other - device not returned; single use device.

• 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: 18192698
• MDR Text Key: 328811991
• Report Number: 1221359-2023-01683
• 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
• Report Date: 01/17/2024

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: 784110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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