MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE OMNI ELECTRODE POTASSIUM; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number	03111628180
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned results for 3 patients tested for potassium (k) on a cobas b 221 system.Based on the data provided, the results for 1 patient are a reportable malfunction.The initial result at 5:59 a.M.Was 6.34 mmol/l.The same sample was repeated at 6:08 a.M.And the result was 7.21 mmol/l.These results were reported outside of the laboratory but the physician dismissed them and no clinical decisions were made.There was no allegation that an adverse event occurred.The b 221 instrument serial number was (b)(4).The k electrode was requested for investigation.
Additional Manufacturer Narrative
The electrode was investigated.A visual inspection showed no obvious issues.The calibration performance of the electrode was investigated over 11 days.No irregularities was detected.A rinse solution pack was changed on the analyzer prior to the sample measurement, but no qc was performed after the solution pack change prior to the sample measurement.Product labeling requires performance of 3 levels of qc after a solution pack change.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ROCHE OMNI ELECTRODE POTASSIUM
• Common Device Name: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7804341
• Report Number: 1823260-2018-02815
• Device Sequence Number: 13738969
• Product Code: CEM
• UDI-Device Identifier: 04015630014293
• UDI-Public: 04015630014293
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K032311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03111628180
• Device Lot Number: 21574849
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 08/06/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 10/15/2018; 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1