MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE INDIRECT NA, K, CI FOR GEN.2; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number 03246353001

Device Problems High Test Results (2457); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they calibrated their ise indirect ci for gen.2 (chloride) test on the cobas 6000 c (501) module - c501 on the morning of (b)(6) 2017.They received no alarms on the calibration and the controls recovered correctly.The customer then stated that they ran an unspecified number of patient samples and all the results were 102.9 mmol/l.At noon on the same day it was not possible to run controls on chloride, although controls for other ise tests were ok.The customer then performed a calibration.The calibration and control recovery passed.The patient samples were repeated and the results were different.There were 14 patient samples that had the initial results of 102.9 mmol/l starting at 9:06 a.M.Of these 14 samples, 2 had erroneous results.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The first sample initially resulted as 102.9 mmol/l and repeated as 88.9 mmol/l.The second sample initially resulted as 102.9 mmol/l and repeated as 87.1 mmol/l.The patients were not adversely affected.The serial number of the c501 analyzer was (b)(4).On (b)(6) 2017 the chloride electrode was replaced.The issue was most likely related to contamination of the electrode.A review of calibration data showed a response time factor associated with almost every calibration performed in (b)(6).Response time increases when contamination is present.

Manufacturer Narrative

Based upon investigations, the results of 102.9 mmol/l can be considered to be correct as 12 of the 14 samples showed a consistent repeat result.The repeat results of 88.9 mmol/l and 87.1 mmol/l are caused by a deteriorated electrode due to contamination.Electrode contamination can be caused by pre-analytic sample handling issues.Investigations also determined that there were no issues with the analyzer software.

• Brand Name: ISE INDIRECT NA, K, CI FOR GEN.2
• Type of Device: ELECTRODE, ION-SPECIFIC, CHLORIDE
• 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: 6405522
• MDR Text Key: 70079649
• Report Number: 1823260-2017-00561
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060373
• 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: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03246353001
• Device Lot Number: B65
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2017
• 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