MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE CALIBRATOR INDIRECT/URINE; CALIBRATOR, MULTI-ANALYTE MIXTURE

Model Number ISE CALIBRATOR INDIRECT

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

The initial reporter stated that she ran calibration and controls on the cobas integra 400 plus in the morning.The reporter stated that she then received an alarm indicating that the na+ electrode and the k+ electrode needed to be changed.The reporter changed the electrodes and then ran an unspecified number of patient samples.She stated that the ise results for these samples did not look right.The reporter then successfully re-calibrated the ise tests and acceptable control results were generated.The samples were repeated.Of the samples that were repeated, five had erroneous initial results that were reported outside of the laboratory for the chloride electrode.The repeat results were believed to be correct.The first sample initially resulted with a chloride value of 125 mmol/l, which repeated as 99 mmol/l.The second sample initially resulted with a chloride value of 123 mmol/l, which repeated as 102 mmol/l.The third sample initially resulted with a chloride value of 122 mmol/l, which repeated as 108 mmol/l.The fourth sample initially resulted with a chloride value of 120 mmol/l, which repeated as 107 mmol/l.The fifth sample initially resulted with a chloride value of 120 mmol/l, which repeated as 106 mmol/l.No adverse events were alleged to have occurred with the patients.The field service engineer determined the issue was caused by the on board ise calibrator indirect solution.He replaced the calibrator solution.The operator ran calibration and controls.Calibration, controls, and patient samples were within range and stable.All analyzer checks passed.Calibration data showed alarms indicating an unstable ise.The investigation determined that the issue was resolved by the service actions.

• Brand Name: ISE CALIBRATOR INDIRECT/URINE
• Type of Device: CALIBRATOR, MULTI-ANALYTE MIXTURE
• 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: 8463730
• MDR Text Key: 140296032
• Report Number: 1823260-2019-01254
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ISE CALIBRATOR INDIRECT
• Device Catalogue Number: 20763063122
• Device Lot Number: 3631270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• 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