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 Code	Pregnancy (3193)
Date of Event	02/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing was performed by (b)(6) on retained kit lot #094901.The retention lot testing yielded expected results when testing internal qc samples.The manufacturing batch records for lot #094901 were reviewed and did not reveal any failures of acceptance criteria.This lot met the required release specifications.A patient sample labeled with the date (b)(6) 2018 (matching the incident date) was returned by the customer and tested at (b)(6) with retained test strips from kit lot #094901.The test result was (b)(6).(b)(6) 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.A review of the complaints reported for (b)(6) or unconfirmed (b)(6) results related to lot #094901 showed that the complaint rate is (b)(4)%.The evidence available suggests that the device lot is performing within labeled claims.
Event or Problem Description
A (b)(6) (plasma) result was obtained with the (b)(6) determine (b)(6) combo test on a (b)(6) year old labor and delivery patient.The patient was in active labor at the time of the testing.There was no anti-retroviral treatment initiated on the mother; however, the newborn received one dose of nebirapine/zidobudine which was discontinued after the confirmatory test result was obtained.

• 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: 7356418
• Report Number: 1221359-2018-00009
• Device Sequence Number: 16511518
• Product Code: MZF
• UDI-Device Identifier: 10811877010323
• UDI-Public: 011081187701032310094901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/20/2018

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: 01/06/2019
• Device Catalogue Number: 7D2649
• Device Lot Number: 094901
• 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: 02/20/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR