MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC BIOPLEX 2200 HIV AG-AB

Model Number N/A

Device Problem False Positive Result (1227)

Patient Problems Anxiety (2328); Confusion/ Disorientation (2553)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

Patient contacted bio-rad directly about what they considered to be a (b)(6) result from (b)(6) 2020.Bio-rad established that the patient did routine blood work at a laboratory on (b)(6) 2020.The initial result came back as (b)(6) on bioplex 2200 hiv ag-ab assay.Bio-rad contacted the clinical laboratory that conducted the test and requested all reidentified testing data and the troubleshooting file from the instrument for the investigation.There were 406 other samples were run at the same time and this is the only sample with showing (b)(6).According to the medical director of the clinical laboratory that performs this test, the retest for this patient was run on another bioplex 2200 instrument and the required confirmatory test was done on 2 additional methods prior to release of the result to the ordering physician.Required confirmatory testing was done per cdc guidelines, and the results were (b)(6).Per bioplex 2200 hiv ag-ab information for user (ifu), initially reactive specimens must be retested in duplicate.If they are repeatedly reactive, they must be investigated by additional, more specific, or supplemental tests.Refer to cdc guidelines for the current recommended hiv testing algorithm.Based on the approved performance of the device it is expected that a certain number of (b)(6) will be observed.As noted the device is intended to be used as an initial screen assay with initial (b)(6) required to be retested and confirmed with a confirmatory assay.On receipt of the initial patient contact in (b)(6) 2021, there was no indication of severe patient anxiety.The patient indicated that the call was simply an inquiry into how our product was to be used.Bio-rad only became aware on april 15th 2021, via review of the fda maude database (mw5098797), that the patient had suffered significant anxiety.

Event Description

Patient contacted bio-rad directly about what they considered to be a (b)(6) result from (b)(6) 2020.The patient did routine blood work at a laboratory on (b)(6) 2020.The result came back as (b)(6) on bioplex 2200 hiv ag-ab assay.Required confirmatory testing was done and the results were (b)(6).On april 14th, 2021 bio-rad became aware from the maude database that the patient reported that she experienced anxiety and confusion/disorientation due to the incorrect result.

• Brand Name: BIOPLEX 2200 HIV AG-AB
• Type of Device: BIOPLEX 2200 HIV AG-AB
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC; 4000 alfred nobel dr; hercules CA 94547
• Manufacturer Contact: arlene carillo ; 5500 e. 2nd st; benicia; 5107414613
• MDR Report Key: 11787941
• MDR Text Key: 249426673
• Report Number: 1000135116-2021-00001
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP140111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2020
• Device Model Number: N/A
• Device Catalogue Number: 665- 3455
• Device Lot Number: 301126
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other