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

Catalog Number	06A36-34
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information was previously reported in 1415939-2017-00166, however a correction on the suspect medical device manufacturer location was identified on 1 november 2017.Customer complaint data was reviewed and no trends or related issues were identified.The prism next operations manual was reviewed and was found to contain adequate instruction for the removal and replacement of the rack plate assembly.In addition, the 2017 ul certification memo indicates abbott diagnostic equipment and accessories are certified to the appropriate us, (b)(6) and international safety standards.Abbott diagnostic division performs an in-depth risk analysis which ensures that the overall residual risk is at an acceptable level.Based on the available information, no product deficiency of the prism next analyzer 06a36-34, was identified.
Event or Problem Description
While servicing the prism analyzer the abbott ambassador injured himself while lifting the sample plate assembly.He had an ultrasound performed and will be undergoing surgery on (b)(6) 2017 due to an aggravated hernia.In addition he cannot lift anything over 20 lbs.

• 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: 6995130
• Report Number: 1628664-2017-00410
• Device Sequence Number: 1353189
• Product Code: MZA
• UDI-Device Identifier: 00380740008574
• UDI-Public: 00380740008574
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BK970042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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: Other
• Device Catalogue Number: 06A36-34
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/01/2017
• 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: Required Intervention