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

Model Number	N/A
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
Additional Manufacturer Narrative
Customer called to see if bio-rad has msds for the (b)(6) qc that one of his technicians accidentally splashed in their eye.Informed him that all the msds can be found on our website searching the product number.He was able to locate the msds so they can determine whether or not she will require medical attention.He said she wasn't in any distress or any pain.They needed to decided whether or not medical attention is going to be required as a safety precaution.Requested he give us a call back and let us know if his employee ends up going for medical treatment.He understood.Bio-ras provided a case # for this accident and followed up with the following questions from which customers replies on 12/01/2016 as follows.Can you describe how the customer splashed her eye: she accidentally dropped one of the qc vials and the liquid splashed upward towards one of her eyes; was he wearing protective eyewear: she was not wearing any sort of ppe, just her glasses but the liquid still got underneath; what was her immediate action/treatment after his eye was splashed with the (b)(6)control material: she sought care from one of the hospital nurses; was there any medical intervention due to the splash or any other medical intervention related to this incident: no medical intervention was deemed necessary at the time; was an internal incident report created by the customer: no incident report was filed by the lab because they didn't feel it was necessary due to the minor accident.The sds of the bioplex 2200 (b)(6)ag-ab control set describes the following biological ingredient as inactivated (b)(6) virus and human serum.Negative control: it contains normal human serum matrix made form defibrinated plasma that is non-reactive for (b)(6); antigen positive control: it contains inactivated (b)(6) through verified to be non-infectious; antibody positive control: it was heat-treated to inactivate the (b)(6) and human sera were tested and found non-reactive for (b)(6) surface antigen and antibodies to (b)(6).Since none of control materials shown above contains infectious agents, the risk to the affected person of having an (b)(6) infection is minimum.
Event or Problem Description
The chemistry supervisor accidently dropped one of the bioplex 2200 ag-ab quality control (qc) vials and the liquid splashed towards her eyes.The operator was not wearing any sort of personal protective equipment (ppe), however she was wearing glasses.Some of the liquid from the qc vial did splash into one of her eyes.The chemistry supervisor immediately sought care from one of the hospital nurses for the splashed liquid in her eye.According to the nurse, no medical intervention was necessary at that time, so no incident report was filed by the lab because they did not feel it was necessary due to the minor accident.Bio-rad laboratories is reporting this adverse event to ensure that the splash has no long term damage to the affected person because of the exposure to the biological materials in the bioplex 2200 ag-ab quality control (qc) vial.

• Brand Name: BIOPLEX 2200 HIV AG-AB CONTROL SET
• Common Device Name: BIOPLEX 2200 HIV AG-AB KIT
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC; 4000 alfred nobel dr.; hercules CA 94547
• MDR Report Key: 6169746
• Report Number: 1000135116-2016-00001
• Device Sequence Number: 185157
• Product Code: MZF
• UDI-Device Identifier: 03610520506493
• UDI-Public: 03610520506493
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: BK140111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 665-3435
• Device Lot Number: 49449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Weight: 68