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

Catalog Number 03263991190

Device Problem High Test Results (2457)

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

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received high results for controls and approximately 300 patient samples tested for crep2 creatinine plus ver.2 (crep) on a cobas 6000 c (501) module - c501.All initial results from these samples were reported outside of the laboratory to the physician.Patient result and control outliers were detected by the customer after their second daily control cycle.Controls were elevated up to about 100%.The customer replaced the reagent cassette and repeated all samples with crep results higher than 1 mg/dl.Upon repeat, the initial results were found to be almost 100-200% higher.The customer provided an example of one patient sample that had an erroneous result that was reported outside of the laboratory.The sample initially resulted as 22.00 mg/dl and when repeated using the new reagent cassette, it resulted as 0.3 mg/dl.The reagent cassette that was in use at the time of the event was placed on the analyzer as a standby cassette.No controls were tested on the cassette prior to use.The affected control and patient values occurred only with this one cassette.The physician was informed about the event and the repeated values.The physician recognized that the values were not plausible.There was no allegation that a patient was adversely affected.The c501 analyzer serial number was (b)(4).The field service engineer checked the reagent pipettor, sample pipettor, and wash unit.He checked the gear pump pressure and it was constant.Tubing was found to be in good condition.On the day of the event, a system reagent bottle was found to be bent and it was replaced.The engineer placed the affected reagent cassette back on the analyzer and measured some patient samples that were within the reference range (below 1 mg/dl).He found the patient results to be 100-200% higher when running these on the affected cassette.The reagent cassette was provided for investigation where it was determined that a reagent bottle in the cassette was contaminated with either creatinine or a substance that reacts with the reagent.It is assumed that the contaminant reaction with the reagent within the bottle had progressed.It was determined that there was no calibration performed on the cassette in question, so the issue with the cassette was not detected.A retention reagent cassette was checked and performance of retention reagent met specifications.

• 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: 6417452
• MDR Text Key: 70426409
• Report Number: 1823260-2017-00581
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 03263991190
• Device Lot Number: 20313801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Date Manufacturer Received: 01/26/2017
• 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