MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PHOS2; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS

Catalog Number	03183793122
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
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 6000 c (501) module (serial number (b)(4) ).No questionable results were reported outside of the laboratory.The sample initially resulted in a phosphate value of 1.0 mg/dl with a data flag.The sample was repeated, resulting in a value of 3.2 mg/dl and this value was deemed correct and reported outside of the laboratory.
Additional Manufacturer Narrative
The calibration performed on 29-jan-2023 was ok and there were no alarms.The same reagent pack was calibrated on 30-jan-2023 and there were variations in the calibration signals.One level of quality control shifted outside of range on 29-jan-2023 and a second level of control shifted outside of range on 30-jan-2023.The field service engineer checked the system and could not find anything wrong.The customer replaced the reagent and no issues were observed.The customer believes the reagent "stayed out for a while".The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: PHOS2
• Common Device Name: PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
• 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: 16398333
• Report Number: 1823260-2023-00500
• Device Sequence Number: 6433363
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951595
• 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): 03/07/2023

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: 01/31/2024
• Device Catalogue Number: 03183793122
• Device Lot Number: 67081901
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 03/07/2023
• 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: 60 YR
• Patient Sex: Female