MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC PRISM NEXT ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number	06A36-11
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the product labeling concluded that the issue is sufficiently addressed.The abbott prismnext operations manual warns of potential biohazards and instructs on the use of gloves, lab coats and protective eye wear when handling human-sourced material or contaminated instrument components.A review for similar complaints was performed from (b)(6) 2011, and no other complaints for the issue were found.Over the 77-month review period, the current complaint is the sole complaint for a splash in the eye with control material against the prism instrument.Additionally, a review of the prism product monitoring review did not identify any trends or related issues.Further, no related nonconformities were found against the prism instrument.Based on the information within the complaint record, the splash in the eye was due to use error as the customer was not wearing protective eye wear as instructed per the abbott prismnext operations manual while in close proximity to dispensing of control material.In summary, this investigation does not indicate any systemic issues pertaining to the abbott prism instrument; no product deficiency was identified.
Event or Problem Description
The account stated an employee's eye was splashed with a02 control.The operator was preparing validation samples by injecting a02 control into tubes to be placed on the prism analyzer.A technician was standing close by and got splashed in the eye.The technician was not wearing eye protection and rinsed eyes for 15 minutes.The technician is preventatively taking dolutegravir and emitricitabine -tenofovir and is doing ok.

• Brand Name: PRISM NEXT ANALYZER
• Common Device Name: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7081819
• Report Number: 1628664-2017-00511
• Device Sequence Number: 1157159
• Product Code: MZA
• UDI-Device Identifier: 00380740008420
• UDI-Public: 00380740008420
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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: Health Professional
• Device Catalogue Number: 06A36-11
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIST 03E60-11, LOT 77005M500; PRISM POSITIVE RUN CONTROL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR