MAUDE Adverse Event Report: MISHIMA DISCRETE MFG IO DXC 700 AU CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	DXC 700 AU-10DE, CHEMISTRY ANALYZER DXC 700 AU FOR DIRECT TR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Beckman coulter application specialist assisted the customer evaluated the dxc 700 au clinical chemistry analyzer.The customer during troubleshooting found the roller tubing was damaged and flat.The customer replaced the roller tubing to resolve the issue.The system performance was verified successfully.The customer was satisfied with support.Section a2, a4, and a5: see section b6 for patient details.Section e1, initial reporter telephone number is (b)(6).The beckman coulter internal identifier is case (b)(4).
Event or Problem Description
The customer reported the generation of erroneously high creatinine (cre) results for one (1) female neonatal patient sample involving their dxc 700 au clinical chemistry analyzer.The neonatal female patient was born in (b)(6) 2023 had been diagnosed with alveolar rhabdomyosarcoma and was receiving chemotherapy treatment.Due to the worsening kidney function, the patient hospitalization was prolonged.The patient hospitalization was prolonged due to false high cre results.

• Brand Name: DXC 700 AU CLINICAL CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): MISHIMA DISCRETE MFG IO; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): MISHIMA DISCRETE MFG IO; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 20670326
• Report Number: 9612296-2024-00456
• Device Sequence Number: 15280012
• Product Code: JJE
• UDI-Device Identifier: 14987666542514
• UDI-Public: (01)14987666542514(11)230428
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K161837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DXC 700 AU-10DE, CHEMISTRY ANALYZER DXC 700 AU FOR DIRECT TR
• Device Catalogue Number: B86446
• Device Lot Number: N/A
• 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: 10/31/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female