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

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at alere (b)(4) on retained kit lot 101191 with the following internal whole blood control samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 101191 were reviewed.This lot met the required release specifications.A review of similar complaints reported related to lot number 101191 showed that the complaint rate is (b)(4).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 multiple instances of (b)(6) results within the read-time window (20 to 30 minutes) with the alere determine hiv 1/2 ag/ab combo.The sample(s) used were fingerstick whole blood.It was reported that (b)(6) results would be seen at 20-21 minutes and then appear (b)(6) by 30 minutes.The (b)(6) results suggest a possible malfunction as it is unknown which result is correct.This was reported for multiple kits and users.One lot number was provided.The exact number of instances of occurrence is 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: 8088818
• MDR Text Key: 127878393
• Report Number: 1221359-2018-00550
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310101191
• 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: 11/20/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2019
• Device Catalogue Number: 7D2648
• Device Lot Number: 101191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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