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	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was regarding an employee who had an exposure to blood product from a source patient with a reported (b)(6) result with the alere determine hiv 1/2 ag/ab test.Testing was performed on retained kit lot 090156 with the following internal serum/plasma control samples: (b)(6).The kit performed as expected.Additionally, qc data and batch records for lot 090156 were reviewed.Release testing was valid and the lot was found to be performing as expected.A review of the complaints reported false positive or unconfirmed (b)(6) related to lot number 090156 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 that an employee was exposed to blood product from a source patient with a (b)(6) result on a serum sample tested with the alere determine hiv 1/2 ag/ab combo.The exposed employee was not tested with alere determine hiv 1/2 ag/ab combo.The employee was started on postexposure prophylaxis (pep) as a result of the preliminary positive result from the source patient.Employee gender, pregnancy status, and outcome were unknown.There is insufficient information to determine if a malfunction occurred.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 fda observation from an fda inspection conducted (b)(4) to (b)(4) 2018 at alere (b)(4), inc.((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: 7591053
• Report Number: 1221359-2018-00322
• Device Sequence Number: 13505312
• Product Code: MZF
• UDI-Device Identifier: 10811877010323
• UDI-Public: 011081187701032310090156
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 06/12/2018

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: 10/26/2018
• Device Catalogue Number: 7D2649
• Device Lot Number: 090156
• 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: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1