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

Catalog Number 7D2648

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 09/12/2019

Event Type  Injury  

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.No sample was returned for further testing, and no additional information was provided.A review of complaints' trend reveal that all of the alere determine (b)(6) 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 two (2) (b)(6) results with the alere determine (b)(6) ag/ab combo test.This report represents patient two (2) of two (2).A (b)(6) (ag/ab not specified) on an unknown sample type was reported with the alere determine (b)(6) ag/ab combo.Confirmation testing is unknown.The patient was reported as a pregnant female.Based on the alere determine (b)(6) ag/ab combo results, cesarean section.Patient treatment and outcome is unknown.Attempts to gain additional information was not successful.Per the alere determine (b)(6) ag/ab combo product insert: a (b)(6) result using alere determine (b)(6) ag/ab combo suggests the presence of (b)(6) p24 antigen and/or antibodies to (b)(6) in the sample.The (b)(6) result is interpreted as preliminary (b)(6) for (b)(6) p24 antigen and/or antibodies to (b)(6).Alere determine (b)(6) ag/ab combo is intended as aid in the diagnosis of infection with (b)(6).(b)(6)test results should be confirmed by additional testing using other tests.Women who present in labor without prior (b)(6) testing may be tested with rapid (b)(6) testing.While waiting for confirmatory test results, a pregnant woman with a (b)(6) rapid (b)(6) test may be managed as if (b)(6) infected to prevent perinatal (b)(6) transmission and may be assigned a c-section.In this event, the case shall be reported as a serious injury as this scenario presents a moderate risk of adverse health consequences in addition to prolonged hospitalization.

• Brand Name: ALERE 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 Contact: erin rowley ; 10 southgate road; scarborough, ME 04074 ; 2077305858
• MDR Report Key: 9606645
• MDR Text Key: 189483774
• Report Number: 1221359-2020-00004
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization
• Patient Age: 29 YR
• Patient Weight: 82