MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number 05168589190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for two samples from the same patient tested with crep2 creatinine plus ver.2 on a cobas 8000 c 702 module.The erroneous results were reported outside of the laboratory to the doctor.The doctor did not believe the results fit the clinical picture of the of the patient since the patient normally has a stable crep2 value of 20 umol/l.The initial result was 5 umol/l.The sample was repeated, resulting as 16 umol/l.A new sample was tested for crep2 on (b)(6) 2018, resulting with a value of 20 umol/l.This sample was repeated, resulting as 5 umol/l.The patient was treated with high doses of piperacillin and tobramycin on (b)(6) 2018.The doctor believed that these 2 antibiotics may be causing an interference with the assay.No adverse events were alleged to have occurred with the patient.The c 702 analyzer serial number is (b)(4).

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CREATININE PLUS VER.2
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7897919
• MDR Text Key: 121463155
• Report Number: 1823260-2018-03231
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (y/n): N
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168589190
• Device Lot Number: 35181201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTIBIOTICS; DEXAMETHASONE; HYDROCORTISONE; MERCAPTOPURINE; PIPERACILLIN; TOBRAMYCIN
• Patient Age: 24 MO