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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-RAD LABORATORIES INC. BIOPLEX HIV AB-AG; TEST, HIV DETECTION
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BIO-RAD LABORATORIES INC. BIOPLEX HIV AB-AG; TEST, HIV DETECTION Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Anxiety (2328); Confusion/ Disorientation (2553)
Event Date 08/21/2020
Event Type  Injury  
Event Description
Severe anxiety and confusion; hi i'm a patient from (b)(6), i had a routine blood work that included (b)(6) screening using bioplex 2200.My screening came back (b)(6) for (b)(6) however was (b)(6) by further testing in other platforms and i also didn't have any clinical reasons for (b)(6) which confused all clinicians involved in my case.During the process i ran into someone else who also had the same exact issue with this platform around the same time in the us as well so this seems to be glitches that is happening with bioplex biorad.I contacted the company to see if they know anything about this maybe covid is causing cross reaction? they didn't respond to me but i really believe this needs to be investigated since it happened to two low risk individuals from the us with further (b)(6) testing.Best.Fda safety report id # (b)(4).
 
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Brand Name
BIOPLEX HIV AB-AG
Type of Device
TEST, HIV DETECTION
Manufacturer (Section D)
BIO-RAD LABORATORIES INC.
MDR Report Key11163412
MDR Text Key227029784
Report NumberMW5098797
Device Sequence Number1
Product Code MZF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age28 YR
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