MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH ALERE DETERMINE HIV 1/2 AG/AB COMBO; VD FOR HIV AG/AB,

Catalog Number	7D2648
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported ten (10) antigen negative results on known positive lab serum samples with the alere determine hiv 1/2 ag/ab combo.The samples with the highest viral load were repeated with negative results.The customer reported no confirmation method was used as facility only has alere determine hiv 1/2 ag/ab combo kit.Attempts to gain further information were unsuccessful.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclusion.Please see updates: g3, g6, h2 and h6.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 153827 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 153827 and device part number 10732998 / lot 147206.The lot met the required release specifications.The current overall incident rate for false negative patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is 0.005%.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is patient sample interference.Substances in the sample itself may have interfered with the reaction.A review of complaints against the kit lot for the reported issue indicates product performance is as expected and a product deficiency has not been identified.Based on the above summary, the investigation is deemed closed.The product will continue to be monitored and tracked.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO
• Common Device Name: VD FOR HIV AG/AB,
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCABOROUGH; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: kindra sudduth ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 11881632
• Report Number: 1221359-2021-01371
• Device Sequence Number: 3910453
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310153827
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: 7D2648
• Device Lot Number: 153827
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown