MAUDE Adverse Event Report: BECKMAN COULTER INORGANIC PHOSPHOROUS; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS

Model Number	AU5811-02, CHEMISTRY ANALYZER, AMERICA, 210V, AU5800 1U
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Beckman coulter complaint handling unit reviewed the available information and assessed the event.Aacc (american association for clinical chemistry) effects on clinical laboratory tests website and young¿s effects of drugs on clinical laboratory tests 5th edition were reviewed to assess interference due to medications.Amphotericin b is not listed as a known drug interference.However, in 2017 there was an article in clinical biochemistry regarding amphotericin b interference with the au inorganic phosphorus assay on the au680 and au5800 analyzer.The article mentioned the use of amphotericin b caused pseudohypophosphatemia with the au phosphorus method.The customer information and clinical biochemistry article were reviewed by au product sme, dr (b)(6).The data generated during the study in 2017 conclusively demonstrate the impact of amphotericin b liposomal on the recovery of inorganic phosphorus results.The authors of clin.Biochem.50 (2017)967-971 have shown it to be an optical interference due to the bright yellow colour of amphotericin b with both lambda 1 (340nm) and 2 (380 nm) of the au test method.The interference with lambda 2 was bigger so that a larger od was subtracted from lambda 1 and the resulting test absorbance/test concentration was smaller.The reaction monitors from the customer account (provided on 01-apr-2020) show a similar pattern.The customer used inorganic phosphorus, catalog number osr6222.This drug interference is not lot specific and would affect all lot of inorganic phosphorus osr6x22.Age, weight, and ethnicity: information not provided by customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
On 28-february-2020, the customer reported the generation of false low phosphorus result for one (1) patient on the au5800 clinical chemistry analyzer.The doctor questioned the patient results as they did not match the patient clinical presentation.The patient had been treated with an iv administration of amphotericin b liposomal at 65 mg administered over 120 mins prior to the blood draw.Liposomal amphotericin-b (l-amb) is a formulation of amphotericin b that has been embedded in a unilamellar phospholipid bilayer.This specific formulation is less toxic and has been approved for invasive aspergillus, candida, and cryptococcus infections at dosages from 3 to 6 mg/kg/day.On 01-april-2020, the customer notified beckman coulter that the patient was administered potassium phosphate to remediate the ¿low¿ phosphorus levels.A selection of samples from the same patient were sent to another laboratory to confirm the results.The samples were tested using the abbott architect and some results were found discrepant.The variability in results may be explained by the administration of potassium phosphate to remediate the ¿low¿ phosphorus levels.

• Brand Name: INORGANIC PHOSPHOROUS
• Common Device Name: PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 9940986
• Report Number: 9680746-2020-00002
• Device Sequence Number: 11567624
• Product Code: CEO
• UDI-Device Identifier: 15099590020118
• UDI-Public: (01)15099590020118(17)210701(11)190701(10)2582
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K925057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AU5811-02, CHEMISTRY ANALYZER, AMERICA, 210V, AU5800 1U
• Device Catalogue Number: OSR6222
• Device Lot Number: 2582
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other