MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECTRODE CHLORIDE CL/ISE; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number 03003523001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Expiration date the expiration date is provided as "install before (b)(6) 2018." (b)(4).

Event Description

The customer complained of a questionable ise indirect cl for gen 2 result for 1 patient sample tested on a cobas integra 400 plus.The initial chloride result was 82 mmol/l.The customer stated that following the initial erroneous result there were multiple analyzer alarms.The repeat chloride results were 110 mmol/l with a data flag.The customer repeated the chloride testing after a new successful calibration and got a result of 106 mmol/l.The customer stated that they did not repeat the potassium and sodium testing because the customer believed the original results were acceptable.The erroneous result was not released outside of the laboratory.The chloride result of 106 mmol/l was deemed to be correct and was reported outside of the laboratory.There was no adverse event.The integra 400+ serial number was (b)(4).On (b)(6) 2018 the customer tried calibrating the ise's multiple but the chloride calibration kept failing.The customer had to install a previous chloride electrode of the same lot to ge a successful calibration and qc results.The customer declined to have service dispatched and stated that they have not had any further issues.Further investigation determined that calibration and qc results prior to the event were acceptable.It was determined that the root cause may be related to the glue that is used to fix the membrane to the electrode housing which can cause the membranes to not be properly fixed and tight.

• Brand Name: ELECTRODE CHLORIDE CL/ISE
• 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: 7515033
• MDR Text Key: 108367817
• Report Number: 1823260-2018-01505
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 05/15/2018

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 Expiration Date: 05/18/2018
• Device Catalogue Number: 03003523001
• Device Lot Number: 21574847
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/15/2018
• 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
• Patient Age: 50 YR