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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T; TEST, HIV DETECTION
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T; TEST, HIV DETECTION Back to Search Results
Catalog Number 7D2648
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2022
Event Type  malfunction  
Manufacturer Narrative
The event date provided in this section was an approximation, it was not provided by customer.The investigation is still in progress.A supplemental report will be provided after completion.
 
Event Description
The consumer reported two false positive results with the determine hiv 1/2 ag/ab combo performed on unknown date.This mfr report addresses test one (1) of two (2).The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on unknown date and type of sample.No additional patient information, including treatment and outcome, was provided.
 
Event Description
The consumer reported two false positive results with the determine hiv 1/2 ag/ab combo performed on unknown date.This mfr report addresses test one (1) of two (2).The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on unknown date and type of sample.No additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.D1, d4-udi h3 other text : device discarded, single use device.
 
Manufacturer Narrative
The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.Incorrect date was inadvertently reported on supplemental 1- in g3 as 28sep2022, it should be 07nov2022.H3 other text : device discarded, single use device.
 
Event Description
The consumer reported two false positive results with the determine hiv 1/2 ag/ab combo performed on unknown date.This mfr report addresses test one (1) of two (2).The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on unknown date and type of sample.No additional patient information, including treatment and outcome, was provided.
 
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Brand Name
ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
Type of Device
TEST, HIV DETECTION
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key15639964
MDR Text Key306700401
Report Number1221359-2022-10016
Device Sequence Number1
Product Code MZF
UDI-Device Identifier00811877011101
UDI-Public00811877011101
Combination Product (y/n)N
PMA/PMN Number
BP120037-0
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup
Report Date 01/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7D2648
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/10/2023
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 Number1
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