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

Model Number 2261

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2022

Event Type  malfunction  

Event Description

Customer submitted a medwatch user facility report (b)(4) that indicated that a gem premier 4000 experienced four consecutive cartridge failures.After the reported cartridge failures, werfen service replaced the heater assembly which returned the instrument to operational condition.Date of event indicated (b)(6) 2022.

Manufacturer Narrative

The user facility report indicated that the service was completed following the failure of four cartridges.Service took place on (b)(6) 2022, between the third and fourth cartridge failures.A review of complaints identified four cartridge failure complaints.Two cartridge failures occurred on (b)(6) 2022, a third on (b)(6) 2022 and a fourth on (b)(6) 2022.Service was completed on (b)(6) 2022, during which the instrument's heater assembly was replaced and all system checks were completed; the instrument was fully operational and ready for normal use.Investigation of the complaints revealed that reported issues were related to individual cartridge issues and not the instrument.The first cartridge failure was due to error 2016 (ground voltage error).The subsequent cartridge failures were due to process control solution not detected.There was no known patient impact.Unable to determine the cause of the cartridge failures.The instrument operated as intended.There is no indication of a product quality issue with respect to manufacture, design, or labeling.As a precaution, the heater assembly was replaced on the instrument.However, investigation did not determine that the cause of the issue was instrument related.

• Brand Name: GEM PREMIER 4000
• Type of Device: CLINICAL CHEMISTRY INSTRUMENT
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 15642141
• MDR Text Key: 307186000
• Report Number: 1217183-2022-00007
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1