MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	I400+
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable mg2 magnesium gen.2 results for 2 patient samples on a cobas integra 400 plus module.For patient id (b)(6), the initial mg2 result was 3.4 mg/dl.The repeat result was 2.0 mg/dl.For patient id (b)(6), the initial mg2 serum result was 3.5 mg/dl.The repeat serum result was 2.2 mg/dl.The customer also performed mg2 testing on a plasma sample from the same patient.The result matched the repeat serum result.The initial results were reported outside of the laboratory.The repeat results were deemed correct.The mg2 reagent lot number is 62758601 and the expiration date is 31-dec-2023.
Additional Manufacturer Narrative
The field service engineer found that the cleaner bottle was empty though the analyzer had not alarmed that it was empty.The bottle was replaced.Qc was performed successfully.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration trace showed that calibration was acceptable on the day of the event.The field service engineer (fse) replaced the float switch.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: COBAS INTEGRA 400 PLUS ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15817473
• Report Number: 1823260-2022-03668
• Device Sequence Number: 7101706
• Product Code: JJE
• UDI-Device Identifier: 04015630929818
• UDI-Public: 04015630929818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: 03245233001
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Female