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

Model Number PHOS2

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2022

Event Type  malfunction  

Manufacturer Narrative

Na.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304419774
• Report Number: 1823260-2022-02049
• Device Sequence Number: 1
• Product Code: CEO
• UDI-Device Identifier: 07613336121481
• UDI-Public: 07613336121481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female