MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE ONLINE TDM PHENYTOIN; DIPHENYLHYDANTOIN ENZYME IMMUNOASSAY

Catalog Number	08445567190
Medical Device Problem Codes	Low Test Results (2458); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas pure c 303 is (b)(6).The customer used the reagent pack even if it has exceeded the onboard stability of 12 weeks.The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable phny2 phenytoin results from one patient sample tested on the cobas pure c 303 analytical unit.The doctor contested the initial result because a phenytoin dose was given to the patient, prompting the rerun of the initial patient sample.A new sample was also collected from the patient.The initial result of the initial sample was 0.000000 umol/l with a data flag.The first repeat result of the initial sample was 3.06 umol/l with a data flag.The second repeat result of the initial sample was 3.21 umol/l with a data flag.The initial result of the new sample was 0.0000 umol/l with a data flag.The repeat result of the new sample with dilution was 0.0000 umol/l with a data flag.
Additional Manufacturer Narrative
The customer provided three patient samples for investigation.To confirm the customer's results, the investigation tested the patient samples using the phny2 assay on the cobas c501 and phnym (phenytoin assay using using fluorescence polarisation method) on the cobas integra 400 plus.The investigation could not confirm the customer's results as the patient sample results from both analyzers were above the lower end of the measuring range.The results for both assays were comparable.The customer used the reagent pack even if it exceeded the onboard stability of 12 weeks.Product labeling states "storage and stability - shelf life at 2-8 °c: see expiration date on cobas c pack label; on-board in use and refrigerated on the analyzer: 12 weeks".The investigation determined the event was consistent with the customer's use of a reagent pack that exceeded its onboard stability.The investigation did not identify a product problem.

• Brand Name: ROCHE ONLINE TDM PHENYTOIN
• Common Device Name: DIPHENYLHYDANTOIN ENZYME IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17919236
• Report Number: 1823260-2023-03273
• Device Sequence Number: 19535710
• Product Code: DIP
• UDI-Device Identifier: 07613336157787
• UDI-Public: 07613336157787
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• PMA/510(K) Number: K030428NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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 Catalogue Number: 08445567190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 02/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PHENYTOIN.
• Patient Age: 17 YR
• Patient Sex: Male