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 Type  malfunction  

Manufacturer Narrative

No kit lot number was provided for a specific investigation.No sample was returned for further testing, and no additional information was provided.A review of complaint trends revealed that all of the alere determine hiv ½ ag/ab combo lots are performing according to label claims.The exact root cause of the reported issue could not be determined.The available evidence suggests that the device is performing within labeled claims.

Event Description

A customer reported a false positive result with determine hiv 1/2 ag/ab combo.Sample information was not provided.Information further specifying the false positive result as antigen and/or antibody was not provided.Additional and/or confirmation testing was not provided.Attempts to gain further information were unsuccessful.Customer reported the patient was a double mastectomy cancer patient, and that the false positive result was expected, and not questioned.No further patient information, including pregnancy and art, was provided.There is insufficient information to determine if a malfunction occurred.Per the alere determine hiv-1/2 ag/ab combo product insert limitations: a reactive result using alere determine hiv-1/2 ag/ab combo suggests the presence of hiv-1 p24 antigen and/or antibodies to hiv-1 and/or hiv-2 in the sample.The reactive result is interpreted as preliminary positive for hiv-1 p24 antigen and/or antibodies to hiv-1 and/or hiv-2.Alere determine hiv-1/2 ag/ab combo is intended as aid in the diagnosis of infection with hiv-1/2.Specimens from individuals with toxoplasma igg, human anti-mouse antibodies, rheumatoid factor, elevated triglycerides (above 600 mg/dl), herpes simplex virus infection, hospitalized and cancer patients may give false positive 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: 10568561
• MDR Text Key: 208158565
• Report Number: 1221359-2020-00289
• Device Sequence Number: 1
• Product Code: MZF
• 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: 09/18/2020

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 Catalogue Number: 7D2648
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: No
• 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