MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2 CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number 03263991190

Device Problem Low Test Results (2458)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for crep2 creatinine plus ver.2 (cre) on a cobas integra 400 plus (i400+).A sample from the patient was tested and resulted as 27 umol/l.This value was reported outside of the laboratory.A sample from the patient was tested on (b)(6) 2017, resulting as 165 umol/l.This sample was tested using a different reagent pack.It was asked, but it is not known if the 27 umol/l value and 165 umol/l value were from the same sample.The doctor said that the correct value for the patient is about 165 umol/l, because the patient suffers from a kidney disease.No adverse events were alleged to have occurred with the patient.The i400+ analyzer serial number was asked for, but not provided.

Manufacturer Narrative

The customer mentioned that only one test was remaining in the cre reagent cassette when the low patient result was measured.The customer stated that this same situation occurred a few months ago, but provided no details.The customer assumed the issue to be related to the low volume in the reagent cassette.The reagent cassette was on board the analyzer for less than 4 weeks.A specific root cause could not be determined based on the provided information.Calibration, quality controls, and the performed check test were all good.Wash steps were programmed on the analyzer.Between the first and second measurement of the patient sample, there was a change in the reagent cassette.The low cre result was the last measurement performed out of the tests ordered on the sample.The system pipetted some other patient samples in between test measurements of the complained sample.No alarm was issued during the pipetting of the sample.The reaction curves for all other parameters tested on the patient sample appeared normal, only the cre result reaction curve was abnormal.It is assumed that some debris or something else was transferred into the reaction cell during measurement of the sample.It is also possible that sample material from other patient samples may have been transferred into the reaction cell as other patient samples were measured in between measurements of the complained sample.It is highly unlikely that only the last measurement out of a reagent cassette would cause an issue.The cassette contains enough dead volume of reagent to prevent this.

• Brand Name: CREP2 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: 6663474
• MDR Text Key: 78401343
• Report Number: 1823260-2017-01329
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03263991190
• Device Lot Number: 242159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• 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: 74 YR