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

Catalog Number 7D2648

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at alere scarborough on retained kit lot 101439 with the following internal whole blood and serum plasma control samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 101439 were reviewed.This lot met the required release specifications and there were no notes indicating conflicting results within the 20-30 minutes reading timeframe.A photograph of the test device which was provided by the customer was reviewed.A single alere determine hiv 1/2 ag/ab combo test device was observed with a valid control line, and a visible ag line.No ab line was visible.The sample pad was observed to be saturated, and the sample appeared to migrate completely up the test strip.A review of the complaints reported conflicting results related to lot number 101439 showed that the complaint rate is (b)(4).The evidence available does not indicate that the product is performing outside label claims.Alere (b)(4) was unable to determine the exact root cause of the reported issue.The available evidence suggests that this device lot is performing within labeled claims.

Event Description

A customer reported an alere determine hiv 1/2 ag/ab combo test result was initially read as (b)(6) at 20 minutes and then appeared (b)(6) for ag (faint line) at or before 30 minutes.The patient was retested with the alere determine hiv 1/2 ag/ab combo on a different day, and the results were (b)(6) at 30 minutes.The conflicting results originally observed on the first test within the reading time-frame of 20-30 minutes, suggest a malfunction may have occurred as the results would be expected to be the same.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO
• Type of Device: IVD FOR HIV AG/AB
• Manufacturer (Section D): ALERE SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: benjamin crystal ; 10 southgate road; scarborough, ME 04074 ; 2077305820
• MDR Report Key: 8349653
• MDR Text Key: 139183495
• Report Number: 1221359-2019-00009
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310101439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP120037-0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Catalogue Number: 7D2648
• Device Lot Number: 101439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1