MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS

Catalog Number	10759350360
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The field service representative found the calibrator lots were not updated in the software and were in the wrong position on the calibrator rack.The calibrator lot numbers and values were updated, the calibrators were repositioned on the rack, and files were updated in the software.Calibration was successful and qc passed on all tests.A precision test was performed with acceptable results.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine jaffé gen.2 results for approximately 8 patient samples on a cobas integra 400 plus analyzer.The customer provided 3 examples.Patient 1: the initial result was 2.9 mg/dl and the repeated result was 1.08 mg/dl.Patient 2: the initial result was 3.1 mg/dl and the repeated result was 0.86 mg/dl.Patient 3: the initial result was 3.1 mg/dl and the repeated result was 0.82 mg/dl.The questionable results were reported outside the laboratory.The samples were repeated because calibration and qc failed.The repeated results were believed to be correct.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general reagent issue was excluded.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: CALIBRATOR FOR AUTOMATED SYSTEMS
• Common Device Name: CALIBRATOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 20569432
• Report Number: 1823260-2024-03138
• Device Sequence Number: 7988019
• Product Code: JIX
• UDI-Device Identifier: 04015630936342
• UDI-Public: 04015630936342
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062319
• 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): 12/06/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 10759350360
• Device Lot Number: 72001601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/06/2024
• 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 Age: 84 YR
• Patient Sex: Male