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

Model Number	2261
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1217183-2022-00007
• Device Sequence Number: 12356643
• Product Code: CHL
• UDI-Device Identifier: 08426950452591
• UDI-Public: 08426950452591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 00025000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown