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

Model Number 00024019255

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2018

Event Type  Injury  

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 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
• Type of Device: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY; 180 hartwell rd; bedford MA 01730
• Manufacturer Contact: reba daoust ; 180 hartwell rd; bedford, MA 01730 ; 7818614364
• MDR Report Key: 7799187
• MDR Text Key: 117694742
• Report Number: 1217183-2018-00008
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 08426950870227
• UDI-Public: 08426950870227
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 00024019255
• Device Catalogue Number: 2262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR