MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MYCOPHENOLIC ACID; MYCOPHENOLIC ACID TEST SYSTEM

Catalog Number	04357213190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with mpa mycophenolic acid on a cobas 6000 c (501) module (serial number (b)(4).The sample value did not correspond to the patient's condition.The sample resulted in a mycophenolic acid value of 2.37 ug/ml when tested on the c501 analyzer.The value was reported outside of the laboratory to the patient's doctor.The value did not agree with the patient's condition.The sample was sent to a second site where it was tested using an unknown method on a siemens analyzer and the result was similar to the one obtained on the c501 analyzer.
Additional Manufacturer Narrative
Quality controls are within range except the first level of control drifts upward.No level 1 control information was available for the time of the incident.The last 10 calibrations were stable.The patient's fluconazole medication does not interfere with the assay and interference with the piracetam medication is unlikely.The investigation determined that the issue is consistent with high diuresis and high amounts of herbal infusion.A product problem can most likely be excluded.

• Brand Name: MYCOPHENOLIC ACID
• Common Device Name: MYCOPHENOLIC ACID TEST SYSTEM
• 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: 15089564
• Report Number: 1823260-2022-02172
• Device Sequence Number: 20109015
• Product Code: OAV
• UDI-Device Identifier: 04015630997381
• UDI-Public: 04015630997381
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K063520
• 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): 09/14/2022

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 Catalogue Number: 04357213190
• Device Lot Number: 570241
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CELLCEPT; FLUCONAZOLE (3 TIMES WEEKLY); HERBAL INFUSIONS; PIRACETAM (TWICE DAILY)
• Patient Sex: Male