MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS 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)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

The required information to enable further investigation, such as the kit's lot number, was not available and therefore a root cause investigation was not performed.A review of complaints' trend reveal that all of the alere determine hiv 1/2 ag/ab combo batches are performing according to label claims.The exact root cause of the reported issue could not be determined.Attempts to gain additional information were not successful.

Event Description

A customer reported (b)(6) results had occurred with the alere determine hiv 1/2 ag/ab combo since (b)(6) 2019.No details regarding confirmatory testing was provided.There is insufficient information to determine if a malfunction occurred.The exact number of patients verses test results is unknown.The customer stated that one patient may have been pregnant (but was unsure).No other patient details such as treatment or patient outcomes were provided.No exact dates of occurrences or device lot numbers were provided.Attempts to gain additional patient information were not successful.

Event Description

Based on new information received from the customer, this report represents the 1st of 3 false positive patient results which occurred with the alere determine hiv 1/2 ag/ab combo on blood samples.A confirmatory test (not otherwise specified) which was performed at quest diagnostics was negative for hiv.There is insufficient information to determine if a malfunction occurred.The patient was reported as female but pregnancy and treatment status were not provided.

Manufacturer Narrative

Testing was performed at alere scarborough on retained kit lot 103698 with the following internal whole blood control samples: hiv-1 positive, hiv-2 positive, p24 positive, and hiv negative.All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 103698 were reviewed.This lot met the required release specifications.A review of the complaints reported as false positive or unconfirmed false positive related to lot number 103698 showed that the complaint rate is 0.02%.The evidence available does not indicate that the product is performing outside label claims.Alere scarborough 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.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO
• Type of Device: IVD FOR HIV AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 8734384
• MDR Text Key: 191855233
• Report Number: 1221359-2019-00037
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP120037-0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2020
• Device Catalogue Number: 7D2648
• Device Lot Number: 103698
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR