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	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing was performed on retained kit lot 161101 with the following internal whole blood control samples: (b)(6).The kit performed as expected.Additionally, qc data and batch records for lot 161101 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 161101 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
Customer reported (b)(6) ag/ab result on fingerstick sample tested with the alere determine hiv 1/2 ag/ab combo.Customer repeated test twice with same result.Geenius (b)(6) confirmatory test was (b)(6).There is insufficient information to determine if a malfunction occurred.Patient gender, pregnancy status, treatment and patient outcomes were unknown.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), inc.; 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: 7587576
• Report Number: 1221359-2018-00191
• Device Sequence Number: 2281996
• Product Code: MZF
• UDI-Device Identifier: 07290015003742
• UDI-Public: (01)07290015003742(17)180319(10)161101
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/11/2018

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: 03/19/2018
• Device Catalogue Number: 7D2649
• Device Lot Number: 161101
• 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: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1