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

Model Number C501

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

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 first sample also had discrepant results for ise indirect cl for gen.2.No incorrect results were reported outside of the laboratory.The reporter noted that electrodes were changed earlier in the day.Calibration and controls were tested prior to running the patient samples and these recovered within range.The first sample initially resulted with a k value of 3.62 mmol/l, which repeated as 5.06 mmol/l.The sample was tested in a second laboratory on another c 501 analyzer, resulting with a k value of 3.6 mmol/l and this value was believed to be correct.The same sample initially resulted with a cl value of 87.5 mmol/l, which repeated as 67.1 mmol/l.The sample was tested in a second laboratory on another c 501 analyzer, resulting with a cl value of 110 mmol/l and this value was believed to be correct.The second sample initially resulted with a k value of 4.49 mmol/l, which repeated as 3.6 mmol/l.The repeat value was believed to be correct.The k and cl electrode lot numbers and expiration dates were requested, but not provided.

Manufacturer Narrative

The last calibration was performed on (b)(6) 2020.The initial calibrations were successful and later calibrations had multiple calibration errors.Quality controls for k and cl run prior to the issue were within range, showing no indication of a reagent performance issue.Sample centrifugation speed is higher than recommended and the centrifugation time is shorter than recommended.Upon review of the alarm trace, multiple errors occurred around the time of the event, including calibration errors, abnormal internal standard reagent concentration, ise noise, and ise voltage errors.The field service engineer changed the chloride electrode.The investigation determined the service actions resolved the issue.Medwatch fields have been updated.

• 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
• MDR Report Key: 10521536
• MDR Text Key: 242855005
• Report Number: 1823260-2020-02206
• Device Sequence Number: 1
• Product Code: CGZ
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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: 03246353001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1