MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY GEM PREMIER 4000; CLINICAL CHEMISTRY INSTRUMENT

Model Number	2261
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	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Data review showed that response from the customer's lis for queries of the two mrn's was "patient has not been found".This is consistent with the description in the complaint since patient demographics were not displayed on the analyzer screen after the mrn was entered.The gem premier 4000 were preforming to specification, and no malfunction was identified.The operator entered the medical record number, patient last name and first name manually, which resulted in a transcription error of the mrn's.There was no patient impact.The operator was re-educated on the process to verify patient identifiers.Customer site has applied the correct results to the patients.The connection issue appears to be related to the hospital's lis.No remedial action required.
Event or Problem Description
Complaint stated that there were two sets of blood gas samples analyzed on gem premier 4000 sn (b)(4).The operator entered the patients' first and last names correctly into the gem but incorrectly entered the mrns (medical record numbers).The printouts show the correct patient names and results and the incorrect mrns.The results went to the incorrect patient emr (electronic medical record).There was no patient impact.The results were correctly applied to the correct emr and removed from the incorrect emr.

• Brand Name: GEM PREMIER 4000
• Common Device Name: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• MDR Report Key: 7650838
• Report Number: 1217183-2018-00004
• Device Sequence Number: 16583053
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1