MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AVL K+ ELECTRODE; ION SPECIFIC POTASSIUM ELECTRODE

Model Number ISE 9180

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received a discrepant result for one patient sample tested with the potassium electrode on a 9180 elecrolyte analyzer.No incorrect results were reported outside of the laboratory.The sample resulted in a potassium value of 3.3 mmol/l when tested on the 9180 analyzer.The sample was tested on a cobas 6000 c (501) module, resulting in a potassium value of 4.40 meq/l.The potassium electrode lot number was 21514679, with an expiration date of 03-jun-2022.

Manufacturer Narrative

Quality controls were within specification on the day of the event.All calibration values were within specifications.Upon review of error reports, there were no relevant error messages aside from a check reference housing error occurring 3 times on (b)(6) 2022 and (b)(6) 2022.The reference and potassium electrodes were provided for investigation.A visual check of the electrodes revealed no obvious damages or strong usages.The customer electrodes were tested on a retention 9180 system.The customer electrodes passed all calibration during the investigation.All controls levels recovered within specifications with the customer electrodes.The customer electrodes were also tested with arterial blood and serum measurements.Comparison measurements were performed with a retention 9180 electrodes and a cobas b 221 instrument.All measurements were stable, without outliers.Arterial blood measurements from the customer electrodes, retention 9180 electrodes, the cobas b 221 followed a similar upwards drift over the duration of the measurements.The serum measurements did not show the upwards drift, which is expected as serum is more stable.The customer allegation could not be reproduced.The investigation could not identify a product problem.The cause of the event could not be determined.The following medwatch fields have been updated: d1, d2, d2b, d4, g1, and g4.

• Brand Name: AVL K+ ELECTRODE
• Type of Device: ION SPECIFIC POTASSIUM ELECTRODE
• 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: 14142882
• MDR Text Key: 289533731
• Report Number: 1823260-2022-01105
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2022
• Device Model Number: ISE 9180
• Device Catalogue Number: 03157334001
• Device Lot Number: 21514679
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/17/2022
• 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
• Patient Sequence Number: 1