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

Catalog Number 03263991190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for one icu patient who had undergone a laparoscopic cholecystectomy and was tested for creatinine plus ver.2 (crep2).The erroneous results were reported outside of the laboratory.Prior to the operation, on (b)(6) 2016 the patient had a crep2 result on a c501 instrument of 400++ umol/l.A day after the operation, on (b)(6) 2016, a new sample was obtained and the crep2 result on the c501 instrument was 73 umol/l.The physician questioned the result and sent the sample from (b)(6) 2016 to an external laboratory where the result from a siemens instrument using the picric acid method was 400 umol/l.The customer decided to repeat both samples on (b)(6) 2016.The initial sample from (b)(6) 2016 was tested on a c702 instrument and the creatinine jaffe gen.2 (crej2) result was 486 umol/l.The crep2 repeat result from a c502 instrument was 469 umol/l.The sample from(b)(6) 2016 was repeated on the c702 instrument and the crej2 result was 383 umol/l.The crep2 repeat result from the c502 instrument was 161 umol/l.It was noted that all samples obtained were venous.No adverse event occurred.The patient is being administered the antibiotic sulperazone which is a third generation cephalosporin.It was suggested that there may be an interference with the crep2 assay.It was noted that product labeling for crej2 indicates that antibiotics containing cephalosporin can lead to significant false positive values.This explains the higher crej2 results.Based on the calibration and quality control information, there is no issue with the crep2 reagent or the instrument.

Manufacturer Narrative

Since calibration and quality controls were acceptable a general reagent or hardware issue can be excluded.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.It was noted that dopamine can interfere with crep tests if the patient is treated with high doses or if the blood sample was taken from a venous catheter where the drug was administered.A possible root cause for the discrepant crep2 results might be due to an incorrect blood draw through a venous catheter where dopamine was administered previously.

• 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: 5653316
• MDR Text Key: 45202557
• Report Number: 1823260-2016-00631
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: Medical Assistant
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 03263991190
• Device Lot Number: 115655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• 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