MAUDE Adverse Event Report: BIO-RAD LABORATORIES MULTISPOT HIV-1/HIV-2 RAPID TEST KIT; IVD

Catalog Number 25228

Device Problems False Positive Result (1227); Improper or Incorrect Procedure or Method (2017)

Patient Problem Overdose (1988)

Event Date 03/12/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, bio-rad laboratories technical support department was contacted by a customer regarding a patient sample tested on the bio-rad (b)(6) test kit.The sample was from a patient in labor and delivery and was reported as (b)(6).The customer reported that the result with (b)(6) eia essay tested the next day on the same specimen was (b)(6).Upon review, it was determined that the customer did not follow the appropriate section of the package insert when reporting the result.Specifically, the result was reported as (b)(6) for (b)(6) on (b)(6) rapid test instead of (b)(6) as per page 23 of the (b)(6) rapid test package insert in the interpretation section.That is, use of the (b)(6) kit in a diagnostic algorithm requires both (b)(6) diagnosis to be made.According to the customer, only one (b)(6) was present.Based on the (b)(6) reported, the patient's baby was treated with anti-virals.The samples (2 serum draws and 1 plasma draw) were sent to bio-rad laboratories product support for further testing.The testing confirmed the (b)(6) result on the (b)(6) assay and the non-reactive result obtained on (b)(6) eia assay.The samples were also tested on (b)(6) and the results obtained were (b)(6) and results obtained with the (b)(6) were (b)(6).

• Brand Name: MULTISPOT HIV-1/HIV-2 RAPID TEST KIT
• Type of Device: IVD
• Manufacturer (Section D): BIO-RAD LABORATORIES; redmond WA
• Manufacturer Contact: scott dennis ; 6565 185th ave., n.e.; redmond, WA 98052 ; 4254981741
• MDR Report Key: 3760730
• MDR Text Key: 17391330
• Report Number: 3022521-2014-00001
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP040046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2014
• Device Catalogue Number: 25228
• Device Lot Number: 11126033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1