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

Catalog Number 05168589190

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of erroneous results for 1 patient tested for crep2 creatinine plus ver.2 (crep2) on a cobas 8000 c 702 module.The erroneous results were not reported outside of the laboratory.On (b)(6) 2017 the patient was tested 3 times on different blood collections with crep2 results of 151 umol/l, 130 umol/l and 127 umol/l.On (b)(6) 2017 the patient was tested and the crep2 result was < 3 umol/l.A 1:10 dilution was performed and the result was 87 umol/l.On (b)(6) 2017 a new sample was obtained and the initial crep2 result was < 3 umol/l.A 1:2 dilution was performed and the result was < 3 umol/l.A 1:10 dilution was performed and the result was 120 umol/l.The sample was sent to another laboratory using an integra system with the creatinine jaffe method and the result was 68 umol/l.The patient is on various drugs that are common among many patients.The patient is on carbocisteine.The customer thinks carbocisteine may interfere with the results produced by the crep2 assay.There was no allegation that an adverse event occurred.The c702 module serial number was (b)(4).

Manufacturer Narrative

It was clarified that the result of 156 umol/l was from a 1:10 onboard dilution and was from the same sample.The result of 156 umol/l was not reported outside of the laboratory as it did not fit the patient's history.The customer did report a result of 64 umol/l from the creatinine jaffe method.The customer performed an interference analysis of the patient sample and found that the patient has a large igm kappa paraprotein.This interference is addressed in the product labeling for the assay.Product labeling states "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.".

Manufacturer Narrative

It is currently not known when the patient was started on carbocisteine.The patient was taking 750 mg three times per day.The clinicians have stopped the carbocisteine treatment, but, recent blood test results seem to be the same.On (b)(6) 2017 the patient was tested for crea2 3 times with results of (-) 132 with a data flag (unit of measure not provided), (-) 102 with a data flag and 156.It is not known if these results are from the same sample or different blood collections.It is also not known if these results were obtained after carbocisteine was stopped.This information has been requested.The customer mentioned they have 1 other patient being treated with carbocisteine and there are no issues with the enzymatic creatinine results for that patient.

• Brand Name: CREATININE PLUS VER.2
• Type of Device: ENZYMATIC METHOD, CREATININE
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6903697
• MDR Text Key: 89495820
• Report Number: 1823260-2017-02148
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR