MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. DETERMINE HIV-1/2 AG/AB COMBO; IVD FOR HIV 1/2 AG/AB

Catalog Number 7D2648

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4) inc.On retained kit lot 119305 with the following internal serum/plasma samples: (b)(6), p24 (b)(6), and (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 119305 were reviewed.This lot met the required release specifications.A review of the complaints reported as (b)(6) (including confirmed, unconfirmed, and conflicting) related to lot number 119305 showed that the complaint rate is (b)(6).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 this device lot is performing within labeled claims.

Event Description

The customer reported 13 (b)(6) results with the alere determine (b)(6) ½ ag/ab combo test.The customer stated that the sample type "majority" was serum, "sometimes" edta plasma (numbers of each sample type not provided).The customer also stated that "most" of the (b)(6) results were for antibodies (results not further specified).Confirmation testing performed with centaur 4th generation provided negative results.The customer was unable to provide further details regarding the alere determine (b)(6) ½ ag/ab test.Attempts to gain further information were unsuccessful.The customer confirmed there was no death or serious injury based on the results.The customer stated that "many" of the patients were pregnant and labor and delivery patients (not further specified).No further patient information, including art treatment, impact, and outcome, was provided.Per the alere determine (b)(6) -1/2 ag/ab combo product insert limitations: ·a reactive result using alere determine (b)(6) -1/2 ag/ab combo suggests the presence of (b)(6) p24 antigen and/or antibodies to (b)(6) in the sample.The reactive result is interpreted as preliminary (b)(6) for (b)(6) p24 antigen and/or antibodies to (b)(6) and/or (b)(6).Alere determine (b)(6)-1/2 ag/ab combo is intended as aid in the diagnosis of infection with (b)(6) 1/2.·specimens from individuals with toxoplasma igg, human anti-mouse antibodies, rheumatoid factor, elevated triglycerides (above 600 mg/dl), (b)(6) virus infection, hospitalized and cancer patients may give (b)(6) test results.

• Brand Name: DETERMINE HIV-1/2 AG/AB COMBO
• Type of Device: IVD FOR HIV 1/2 AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer (Section G): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: alonna pitreau ; 10 southgate road; scarborough, ME 04074 ; 2077305717
• MDR Report Key: 10581428
• MDR Text Key: 250323518
• Report Number: 1221359-2020-00293
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310119305
• 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: 09/24/2020

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: No Information
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 119305
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2020
• 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