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 False Positive Result (1227)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190); Pregnancy (3193)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at alere (b)(4) on retained kit lots 102459 and 101439 with the following internal serum plasma control samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lots 102459 and 101439 were reviewed.These lots met the required release specifications.A review of the complaints reported as (b)(6) related to lots 102459 and 101439 showed that the complaint rate is (b)(4), respectively.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 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 these device lots are performing within labeled claims.

Event Description

A customer reported (b)(6) results on a serum plasma sample with the alere determine hiv 1/2 ag/ab combo.A total of 4 test strips from 2 different lots were tested for the single reported patient.There is insufficient information to determine if a malfunction occurred.The results of a (b)(6) test were unknown at the time of reporting.It was indicated that the female patient was pregnant.The patient's treatment and outcome were unknown.

• 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: 8159446
• MDR Text Key: 130179949
• Report Number: 1221359-2018-00551
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310102459
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2019
• Device Catalogue Number: 7D2648
• Device Lot Number: 102459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• 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
• Patient Age: 21 YR