MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY GEM PREMIER 5000; CLINICAL CHEMISTRY INSTRUMENT

Model Number	00024019255
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was insufficient evidence provided to investigate this complaint.The copyildata from the customer's gem premier 5000 was reviewed but was not from the date of the event.An internal test was unable to reproduce the event.There was no malfunction identified and therefore, no remedial action indicated.
Event or Problem Description
The customer reported that a sample was analyzed on a patient and the incorrect patient identifier was entered.However, on noticing this incident, the poct looked in the results on the lis and noticed that the results had transferred to the lis (apex) under the correct patient identifier and not to the incorrect patient identifier.There was no patient impact.

• Brand Name: GEM PREMIER 5000
• Common Device Name: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• MDR Report Key: 7799187
• Report Number: 1217183-2018-00008
• Device Sequence Number: 10793175
• Product Code: CHL
• UDI-Device Identifier: 08426950870227
• UDI-Public: 08426950870227
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

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 Expiration Date: 01/14/2016
• Device Model Number: 00024019255
• Device Catalogue Number: 2262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/20/2018
• 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: 45 YR