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

Catalog Number 03246353001

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

The field service engineer determined the cl electrode was defective.The electrode was causing incorrect ise check test results.The reference and cl electrodes were replaced.All ise sipper flow paths were cleaned and checked.Calibration and controls were run and all results were within specifications.The investigation could not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated they received questionable results for two patient samples tested for ise assays on the cobas 8000 ise module.Of the two samples, one had discrepant results for ise indirect na, ci for gen.2.No incorrect results were reported outside of the laboratory.The sample was repeated on a different analyzer and the repeat results were believed to be correct.The sample initially resulted with an na value of 124 mmol/l, which repeated as 144 mmol/l.The sample initially resulted with a cl value of 112 mmol/l, which repeated as 97 mmol/l.The serial number of the cobas 8000 ise module was (b)(4).

• 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: 9221010
• MDR Text Key: 218992938
• Report Number: 1823260-2019-03830
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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: K7199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• 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