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

Catalog Number ASKU

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

The field service engineer determined there was a failure of the ise electrodes.The ise flow path was cleaned, the sipper nozzle was replaced, the cell rinse mechanism was tightened, squeegees were aligned, and system reagents were replaced.The customer ran calibration and controls; results were within laboratory guidelines.Precision studies were performed and recovered within guidelines.The investigation determined that the service actions resolved the issue.

Event Description

The initial reporter stated that they received questionable results for one patient sample tested for multiple assays on the cobas 6000 c (501) module.Of the mentioned assays, the sample had discrepant results for ise indirect na, k, ci for gen.2.No incorrect results were reported outside of the laboratory.The samples were repeated on a second c501 analyzer and the repeat results were believed to be correct.This medwatch will apply to the cl electrode.Please refer to the medwatch with patient identifier (b)(6) for information related to the na electrode and refer to the medwatch with patient identifier (b)(6) for information related to the k electrode.The sample initially resulted with an na value of 91 mmol/l, which repeated as 138 mmol/l.The sample initially resulted with a k value of 2.6 mmol/l, which repeated as 4.0 mmol/l.The sample initially resulted with a cl value of 68 mmol/l, which repeated as 108 mmol/l.No adverse events were alleged to have occurred with the patient.The c501 analyzer serial number is (b)(4).

• Brand Name: ISE INDIRECT 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: 8736546
• MDR Text Key: 149379338
• Report Number: 1823260-2019-02335
• 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: 06/26/2019

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/26/2019
• 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
• Patient Age: 75 YR