MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE INDIRECT K+ FOR GEN.2; ELECTRODE, ION SPECIFIC, POTASSIUM

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer determined there was a failure of the electrode.The electrodes were replaced and the vacuum vessels were rinsed.Operational and mechanical checks passed.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with ise indirect k for gen.2 on a cobas 6000 c (501) module.The initial values were reported outside of the laboratory.The reporter stated there are two c 501 systems in the same line, serial numbers (b)(4) and (b)(4).The reporter could not confirm which serial number was used to test the affected samples.The reporter mentioned they received ise noise alarms on c 501 serial number (b)(4).A noise alarm was received when calibrating this analyzer on the morning of (b)(6) 2020.The calibration was repeated and there were no further alarms.Controls recovered fine.The first sample initially resulted with a k value of 8 mmol/l, which repeated as 3.9 mmol/l.The second sample initially resulted with a k value of 6 mmol/l, which repeated as 3 mmol/l.The k electrode lot number and expiration date were requested, but not provided.

Manufacturer Narrative

The last calibration performed on (b)(6) 2020 was ok and there were no alarms.Controls recovered within range, showing no indication of a reagent performance issue.The sample centrifugation speed was too high and the time was too short.The investigation determined the service actions resolved the issue.

• Brand Name: ISE INDIRECT K+ FOR GEN.2
• Type of Device: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10384792
• MDR Text Key: 203508630
• Report Number: 1823260-2020-01939
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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 Model Number: C501
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 07/17/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1