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

Catalog Number 11775685216

Device Problem High Test Results (2457)

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

Event Date 11/13/2014

Event Type  malfunction  

Event Description

The customer received questionable creatinine plus results for an unknown number of patient samples from three analytical p module analyzers at the site.Data was provided for three patient samples.Only the serial number for one analyzer, (b)(4) was provided.Patient sample 1 initial result was 243 umol/l and was reported outside the laboratory.The result was questioned and the patient was redrawn on (b)(6) 2014 with a result of 76 umol/l.The first sample was then repeated and the result was 74 umol/l.The patient was suspected to have kidney disease and was investigated for renal impairment, but was not adversely affected.The date of testing for the following samples was not provided.Patient sample 2 initial result was 330 umol/l and the repeat result was 75 umol/l.Patient sample 3 initial result was 154 umol/l and the repeat result was 81 umol/l.Information concerning which of these results was reported outside the laboratory or if the patients were adversely affected was requested, but was not provided.The creatinine r1 reagent lot number was 602987.The expiration date was requested, but was not provided.Review of the reaction monitor for one sample indicated something happened to the reaction when the r2 reagent was added indicating a possible reagent needle carryover from the r2 reagent.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A specific root cause could not be identified.The maintenance status of the analyzer and preanalytical procedures were found to be the main factors influencing the jump in the reaction after r2 reagent addition.Intensive maintenance was performed including replacement of the sample probes, reagent probes and gear pump.

• Brand Name: CREATININE PLUS
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4305541
• MDR Text Key: 5081391
• Report Number: 1823260-2014-09685
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K953239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11775685216
• Device Lot Number: 606111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 11/14/2014
• 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
• Patient Sequence Number: 1
• Treatment: ALENDRONINEZUUR; CALCI-CHEW 500/800; PREDNISONE; PANTAPROZOL
• Patient Age: 033 YR