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

Catalog Number ASKU

Device Problem Low Test Results (2458)

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

Event Date 09/05/2014

Event Type  malfunction  

Event Description

The customer received questionable creatinine plus results for one patient sample from two cobas 8000 analyzers.The serial number for one of the cobas 8000 c701 analyzers was 1167-05.The serial number for the other cobas 8000 was not provided.The results from cobas 8000 #1 were -2.78, -2.29, -3.16, and -2.31.The results from cobas 8000 #2 were -2.35, -2.23, -2.13, and -2.77.When retested, the results were similar.No specific data was provided.The sample was sent to an external laboratory which reported a creatinine enzymatic result of 1.32.No units of measure were provided.Information concerning if any erroneous result was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

Manufacturer Narrative

This event occurred in (b)(6).

• 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: 4206503
• MDR Text Key: 5041561
• Report Number: 1823260-2014-08326
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: ASKU
• Device Lot Number: 601410-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 09/05/2014
• 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: HYPERTENSION MANAGEMENT MEDICATIONS
• Patient Age: 092 YR