MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2; CREATININE TEST SYSTEM

Catalog Number 08057524190

Device Problem High Test Results (2457)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

There was an allegation of a suspected interference with the crep2 assay for 1 patient on a cobas c 503 analytical unit.The suspected interference is with herpes virus drugs (aciclovir and valaciclovir) and cialis (tadalafil) episodically.The serum creatinine result was 119 mol/l.The creatinine urine spot (not 24-hour urine) result was 21.705 mol/l.It was reported that the patient's result is typically low when measured in another laboratory.The values are not known but are most probably in the range of reference values.

Manufacturer Narrative

The analyzer serial number is (b)(6).The sample was requested for investigation, however, it is not available.The investigation is ongoing.

Manufacturer Narrative

Medwatch fields a2, d1-d4 g1, and g4 were updated.The investigation determined the use of acyclovir may lead to kidney damage in a certain percentage of patients taking this drug which may lead to higher creatinine values.There was no interference found with the crep2 assay and no product issue could be identified.

• Brand Name: CREP2
• Type of Device: CREATININE TEST SYSTEM
• 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: 18789009
• MDR Text Key: 336398501
• Report Number: 1823260-2024-00557
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): Y
• Reporter Country Code: WZ
• PMA/PMN Number: K812095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08057524190
• Device Lot Number: 75442801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACICLOVIR; CIALIS (TADALAFIL); VALACICLOVIR
• Patient Age: 77 YR
• Patient Sex: Male