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

Catalog Number	05061482190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na and k electrode lot numbers and the albumin reagent lot number and expiration dates were not provided.The creatinine reagent lot number is 73444601 and the expiration date is 31-mar-2024.The total protein reagent lot number is 75011801 and the expiration date is 31-dec-2024.The field service egnineer (fse) found that the quad seals were misplaced on the mixing tower, a blown fuse, a broken probe, and bad fluid in the onboard bottles.The fse replaced the onboard bottles, cleaned up the leaking fluid from the mixing vessel, replaced the broken probe, and replaced the blown fuse.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na and k, alb2 albumin gen.2, tp2 total protein gen.2, and crep2 creatinine plus ver.2 results for 2 patient samples on a cobas integra 400 plus analyzer.For sample 1, the initial na result was 138.5 mmol/l with flag, the initial alb2 result was 1.3 g/l with flag, and the initial tp2 result was 0.7 g/dl with flag.The sample was sent to another laboratory and the repeat na result was 132 mmol/l, the repeat albumin result was 3.7 g/l, and the repeat total protein result was 6.6 g/dl.For sample 2, the initial creatinine result was 0.13 mg/dl with flag and the initial k result was 3.7 mmol/l.The sample was sent to another laboratory and the repeat creatinine result was 1.17 mg/dl and the repeat k result was 4.3 mmol/l.The repeat results were deemed correct.
Additional Manufacturer Narrative
The field service engineer (fse) found a broken probe and replaced it and performed indirect and direct ise calibration successfully.The customer performed calibration and qc successfully.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; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18526838
• Report Number: 1823260-2024-00158
• Device Sequence Number: 15053542
• Product Code: JJE
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K113521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/08/2024

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 Catalogue Number: 05061482190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown