MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PHOSPHATE (INORGANIC) VER.2; PHOSPHOMOLYBDATE (COLORIMETRIC) - INORGANIC PHOSPHOROUS

Model Number	PHOS2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with phos2 phosphate (inorganic) ver.2 on a cobas c 503 analytical unit (serial number (b)(4)).No incorrect results were reported outside of the laboratory.The sample initially resulted in a phosphorus value of 2.69 mg/dl accompanied by a data flag indicating atypical kinetic behavior.The sample was repeated, resulting in a phosphorus value of 2.68 mg/dl accompanied by a data flag indicating atypical kinetic behavior.The sample was diluted 1:3 and repeated, resulting in a phosphorus value of 2.33 mg/dl accompanied by a data flag.The sample was repeated again at decreased sample volume, resulting in a phosphorus value of 2.55 mg/dl accompanied by a data flag indicating atypical kinetic behavior.The sample was then repeated on a second analyzer at decreased sample volume, resulting in a phosphorus value of 3.54 mg/dl.This value was deemed correct.
Additional Manufacturer Narrative
The customer stated the patient sample was icteric upon visual check.The issue was resolved by re-drawing the patient.The investigation determined the customer actions resolved the issue.

• Brand Name: PHOSPHATE (INORGANIC) VER.2
• Common Device Name: PHOSPHOMOLYBDATE (COLORIMETRIC) - INORGANIC PHOSPHOROUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 14984854
• Report Number: 1823260-2022-02049
• Device Sequence Number: 13887688
• Product Code: CEO
• UDI-Device Identifier: 07613336121481
• UDI-Public: 07613336121481
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K983503
• 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): 08/08/2022

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 Expiration Date: 12/31/2022
• Device Model Number: PHOS2
• Device Catalogue Number: 08058610190
• Device Lot Number: 57951801
• 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: 06/19/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/08/2022
• 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 Age: 46 YR
• Patient Sex: Female