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); No Information (3190)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing was performed on retained kit lot 160712 with the following internal whole blood control samples: (b)(6), (b)(6), p24 (b)(4), and (b)(6).The kit performed as expected.Additionally, qc data and manufacturing batch records for lot 160712 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 160712 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.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
This report represents 1 of 3 (b)(6) (unknown ag/ab) results on fingerstick whole blood samples tested with the alere determine hiv 1/2 ag/ab combo.(b)(4) serum hiv 4th generation test was negative.Patient gender, pregnancy status, treatment and patient outcomes were unknown.There is insufficient information to determine if a malfunction occurred.This will be filed as 3 separate mdr reports.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by alere (b)(4); however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted february 26th to march 2nd, 2018 at alere (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: 7602304
• Report Number: 1221359-2018-00063
• Device Sequence Number: 19282543
• Product Code: MZF
• UDI-Device Identifier: 07290015003735
• UDI-Public: (01)07290015003735(17)171201(10)160712
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/14/2018

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: 12/01/2017
• Device Catalogue Number: 7D2648
• Device Lot Number: 160712
• 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: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1