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

Catalog Number	03111628180
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for two samples from the same patient tested with the roche omni electrode potassium on a cobas b 221 roche omni s6 system.The sample values were reported outside of the laboratory and questioned by a physician as the available outputs from patient monitoring did not suggest that the patient was hypokalemic.The reporter also mentioned they have been getting "sodium signal sensor unstable" errors on the cobas b 221 analyzer for several months.The reporter stated that the k electrode was last changed on this analyzer on (b)(6) 2021.Per product labeling, the k electrode is stable for 26 weeks.The first sample from the patient resulted in a k value of 3.14 mmol/l when tested on the cobas b 221.The second sample from the patient resulted in a k value of 3.14 mmol/l when tested on the cobas b 221.A third sample was collected from the patient and tested on a cobas 6000 c (501) module, resulting in a k value of 4.2 mmol/l.This value was deemed correct by the physician as it was consistent with the clinical presentation of the patient.
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for two samples from the same patient tested with the roche omni electrode potassium on a cobas b 221 roche omni s6 system.The sample values were reported outside of the laboratory and questioned by a physician as the available outputs from patient monitoring did not suggest that the patient was hypokalemic.The reporter also mentioned they have been getting "sodium signal sensor unstable" errors on the cobas b 221 analyzer for several months.The reporter stated that the k electrode was last changed on this analyzer on (b)(6) 2021.Per product labeling, the k electrode is stable for 26 weeks.The first sample from the patient resulted in a k value of 3.14 mmol/l when tested on the cobas b 221.The second sample from the patient resulted in a k value of 3.14 mmol/l when tested on the cobas b 221.A third sample was collected from the patient and tested on a cobas 6000 c (501) module, resulting in a k value of 4.2 mmol/l.This value was deemed correct by the physician as it was consistent with the clinical presentation of the patient.
Additional Manufacturer Narrative
The patient's reason for the visit was abdominal pain.The first sample from the patient resulted in the following additional test data: ph = 7.340, pco2 = 42.7 mmhg, po2 = 435.0 mmhg, chco3st = 21.8 mmol/l, beecf = 3.2 mmol/l, so2 = 99.9 %, cto2 = 9.6 vol%, thb = 6.02 g/dl, hct = 21.7 %, cohb = 1.3 %, o2hb = 98.0 %, hhb = 0.1 %, methb = 0.6 %, ca2+ = 3.13 mg/dl, glu = 138.8 mg/dl.The second sample from the patient resulted in the following additional test data: ph = 7.326, pco2 = 40.5 mmhg, po2 = 413.4mmhg, chco3st = 20.3 mmol/l, beecf = -5.3 mmol/l, so2 = 99.9 %, cto2 = 9.3 vol%, thb = 5.86 g/dl, hct = 20.4 %, cohb = 1.3 %, o2hb = 97.9 %, hhb = 0.1 %, methb = 0.7 %, na = 139.1 mmol/l, ca2+ = 2.78 mg/dl, glu = 141.2 mg/dl.The third sample from the patient resulted in the following additional test data: na = 136 mmol/l, cl = 104 mmol/l, co2 = 23 mmol/l, gap = 9 mmol/l, bun = 11 mg/dl, creat = 0.50 mg/dl, creat calc pha = 50 ml/min, gfr = > 90 ml/min/1.73m^2.Medwatch fields a2.And a3.Have been updated.
Additional Manufacturer Narrative
The affected electrode could not be returned for investigation.The investigation concludes that the k electrode exceeded in-use time and should not have been used.After replacing the electrode, the problem was resolved.

• 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
• 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: 13290645
• Report Number: 1823260-2022-00158
• Device Sequence Number: 2225809
• Product Code: CEM
• UDI-Device Identifier: 04015630014293
• UDI-Public: 04015630014293
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2022

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2022
• Supplement Date Received by Manufacturer: 02/21/2022; 02/21/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/02/2022; 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female