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

Catalog Number 03183793122

Device Problem Low Test Results (2458)

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

Event Date 01/30/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 309975312
• Report Number: 1823260-2023-00500
• Device Sequence Number: 1
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/17/2023
• 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: 60 YR
• Patient Sex: Female