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

Catalog Number	7D2649
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	09/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing was performed on retained kit lot 160515 with the following internal whole blood control samples: (b)(6).The kit performed as expected.Additionally, qc data and batch records for lot 160515 were reviewed.Release testing was valid and the lot was found to be performing as expected.A review of the complaints reported (b)(6) or unconfirmed (b)(6) related to lot number 160515 showed that the complaint rate is (b)(4).The evidence available does not indicate that the product is performing outside label claims.In house testing was unable to determine the exact root cause of the reported issue. .
Event or Problem Description
Customer reported conflicting results on a fingerstick whole blood sample tested with the alere determine (b)(6) ag/ab combo.The same sample was used to perform two tests.The first test result was (b)(6) for ag/ab, and the second test was (b)(6).It is unknown how much time elapsed between the two tests, but it is possible they occurred on the same day.A 4th generation (b)(6) test with venipuncture sample was (b)(6).Based on the information available in the case, it appears a malfunction may have occurred with one of the two conflicting alere determine (b)(6) combo tests.Patient was male transitioning to female transgender individual, with treatment and patient outcome unknown.This mdr is a retrospective filing in response to an fda observation from an fda inspection conducted february 26th to march 2nd, 2018 at (b)(4).

• 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: 7566046
• Report Number: 1221359-2018-00316
• Device Sequence Number: 2629645
• Product Code: MZF
• UDI-Device Identifier: 07290015003742
• UDI-Public: (01)07290015003742(17)171014(10)160515
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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: 10/14/2017
• Device Catalogue Number: 7D2649
• Device Lot Number: 160515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1