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

Catalog Number	7D2648
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Pregnancy (3193)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing was performed at alere (b)(4) on retained kit lot: 099637 and the customer returned kit lot: 099637 with the following internal plasma control samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot: 099637 were reviewed.This lot met the required release specifications.A review of the complaints reporting (b)(6) related to lot number: 099637 demonstrated a complaint rate of (b)(4).The evidence available does not indicate that this product lot is performing outside label claims.Alere (b)(4) was unable to determine the exact root cause of the reported issue.The results obtained may possibly be related to the patient sample.The sample may have contained specific substances which may have affected the results.The available evidence suggests that this device lot is performing within labeled claims.
Event or Problem Description
Two (b)(6) results were reported on a plasma sample tested with the alere determine hiv 1/2 ag/ab combo.(b)(6).The patient was reported as a pregnant female of unknown age.It is unknown if (b)(6) treatment was administered.However, it can be confirmed that medical intervention regarding the pregnancy was not performed.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO
• Common Device Name: IVD FOR HIV AG/AB
• Manufacturer (Section D): ALERE SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 8066426
• Report Number: 1221359-2018-00536
• Device Sequence Number: 11378205
• Product Code: MZF
• UDI-Device Identifier: 10811877010323
• UDI-Public: 011081187701032310099637
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: BP120037-0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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: 10/25/2019
• Device Catalogue Number: 7D2648
• Device Lot Number: 099637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1